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Aspen M2 Afo, Posterior Right, X-Large
EUDAMEDClass I (EU MDR)
Ref 640115Ref 640114
Identity
- Trade Name
- ASPEN M2 AFO, POSTERIOR RIGHT, X-LARGE EUDAMEDASPEN M2 AFO, POSTERIOR RIGHT, LARGE EUDAMED
- Device Name
- ANKLE-FOOT EUDAMED
- Model / Reference
- 640115 EUDAMED640114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249015040 EUDAMED00818249015033 EUDAMED
- Basic UDI-DI
- 081824901AFOEA EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aspen M2 Afo, Posterior Right, X-Large by Aspen Medical Products, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081824901AFOEA | Class I | Active |
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Manufacturer
- Manufacturer
- Aspen Medical Products, LLC
- EUDAMED SRN
- US-MF-000001571
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2fba0285-d16f-4c54-8618-cdcc55934c01 61 fields · synced Oct 6, 2026
- EUDAMED f99dc07c-f39f-4a7c-8bcc-b04b608c5661 61 fields · synced May 17, 2026