CE marking on the Skelex 360 means it meets EU health, safety and environmental rules. Here's what the label does and doesn't prove for industrial buyers.
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Editorial QA
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CE marking is the manufacturer's declaration that the product meets the essential health, safety and environmental requirements of the relevant EU directives or regulations. For a passive shoulder exoskeleton such as the Skelex 360, the applicable framework is normally the Machinery Directive (2006/42/EC) or its successor, the Machinery Regulation (EU) 2023/1230, which applies from January 2027. The Skelex 360 datasheet lists CE certification and references ISO 13482, the standard for personal care robots. That combination tells a buyer the maker has addressed machinery safety and, where claimed, the specific risks of physical human-robot interaction.
What CE does not tell you is how much shoulder relief the device delivers in your task, whether it fits your population, or whether it will be worn after week three. Those are procurement questions, not compliance questions. The Skelex 360 is a passive system with 70 N assist force, 12 Nm assist torque and 0 degrees of freedom, priced from 4,900 USD indicative. CE sits alongside those specs; it does not validate them.
The table below uses only parameters disclosed in the ExoSelect database. Where a value is missing, it is marked Unknown or Not disclosed. This is the fastest way to see that CE is not a differentiator on its own—most industrial systems in this set carry it.
| System | Drive | Certifications | Standards | Weight | Assist force | Price from (USD) |
|---|---|---|---|---|---|---|
| Skelex 360 | Passive | CE | ISO 13482 | 1.6 kg | 70 N | 4,900 |
| MATE-XT | Passive | CE, ISO 13482 | ISO 13482 | 4.2 kg | 100 N | 5,900 |
| AIRFRAME | Passive | CE | Unknown | 1.5 kg | 60 N | 2,950 |
| Apex 2 | Passive | CE | Unknown | 1.2 kg | 220 N | 1,195 |
| Cray X | Active | CE, ISO 13482 | ISO 13482, EN 614-1 | 7.6 kg | 300 N | 9,900 |
Notice the pattern: CE appears across the set, but the standards column is where the real differentiation sits. The Skelex 360 and MATE-XT both cite ISO 13482; the Cray X adds EN 614-1, an ergonomics standard for machinery design. AIRFRAME and Apex 2 list CE without a disclosed standard, which is a gap to raise in tender questions.
The Skelex 360 datasheet is relatively complete at 95% in the ExoSelect completeness score, but several parameters that matter for CE-file review are not disclosed. Clinical evidence is marked unknown. That matters because CE marking does not require clinical trials for a passive industrial exoskeleton; a buyer who needs outcome data for an internal business case will not find it in the certification. Max walking speed, stair/slope capability, battery chemistry, runtime, charge time, hot-swappable battery and connectivity are all marked not applicable—correctly, because the Skelex 360 is passive and untethered. But the absence of connectivity means no usage telemetry, so you cannot verify wear time from the device itself.
Two further unknowns sit outside the product record: the lead time is listed as "Contact maker," and the warranty is 24 months, which is disclosed. What is not disclosed is whether the CE file includes a notified body opinion or is a pure self-declaration. For a passive system, self-declaration under the Machinery Directive is common, but procurement should request the declaration of conformity and the technical file summary. The Skelex 360's height range of 160–195 cm and user weight limit of 110 kg are disclosed and should be checked against your workforce; CE does not guarantee fit.
CE is an EU/EEA mark. The Skelex 360 is listed for Europe and North America, but a CE mark does not automatically satisfy US OSHA or NIOSH guidance, nor does it substitute for a US-specific risk assessment. In North America, the relevant framework is typically ANSI/RIA R15.06 for industrial robots and ANSI/ASSP Z244 for lockout, though exoskeletons often fall into a gap. If you deploy the Skelex 360 in a US plant, the CE file is useful evidence but not the governing compliance document. Ask the maker for the North American conformity package separately. This is the single most common oversight in cross-border procurement.
Do not choose the Skelex 360 if your primary need is powered lift support for the back. It is a shoulder exoskeleton with 5 kg lift support and 0 degrees of freedom; a powered back system such as the Cray X, with 30 kg lift support and 300 N assist force, is the correct category. Also avoid the Skelex 360 if you require documented clinical evidence or usage telemetry to justify the purchase—neither is disclosed, and the passive design has no connectivity. Finally, if your workforce falls outside 160–195 cm or exceeds 110 kg, the CE mark will not save you from a fit failure. In those cases, look at the MATE-XT for a wider height range (155–195 cm) or the Apex 2 for a 125 kg user limit, and verify standards disclosure before tendering.
Ask for four documents: the EU declaration of conformity, the technical file index, the risk assessment covering human-robot interaction, and the ISO 13482 test summary if cited. The Skelex 360 cites ISO 13482, so the test summary should exist. If the maker cannot produce it, treat the ISO reference as marketing until proven. Pair this with a task-based pilot: the CE file proves legal conformity, not that your painters or assemblers will keep the device on for a full shift. For a structured comparison against the MATE-XT and AIRFRAME, use the ExoSelect compare tool and filter on standards disclosure.
No. CE confirms conformity with applicable EU legislation, but it does not certify fit for every body size or task. The Skelex 360 is rated for 160–195 cm and 110 kg; outside that, safety is not established by the mark.
Not always. ISO 13482 is a harmonised standard for personal care robots; citing it gives a presumption of conformity with parts of the Machinery Directive, but a manufacturer can use other routes. The Skelex 360 cites it, which is a positive signal for human-interaction risk.
CE is not a US compliance mark. You will need a separate North American risk assessment and, where applicable, OSHA-related documentation. Ask Skelex for the US conformity package before deployment.
Request the Skelex 360 EU declaration of conformity and the ISO 13482 test summary from the maker, then compare it against the MATE-XT and Cray X on the compare page. If you need help interpreting the compliance file for your site, contact the ExoSelect selection desk with your task profile and workforce anthropometrics.
Editorial note
This analysis is based on published specifications and named sources. No first-party physical evaluation was performed.
Reviewed by the ExoSelect editorial desk
