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Aspen M2 Afo, Posterior Left, Large
EUDAMEDClass I (EU MDR)
Ref 640214Ref 640215
Identity
- Trade Name
- ASPEN M2 AFO, POSTERIOR LEFT, LARGE EUDAMEDASPEN M2 AFO, POSTERIOR LEFT, X-LARGE EUDAMED
- Device Name
- ANKLE-FOOT EUDAMED
- Model / Reference
- 640214 EUDAMED640215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249015071 EUDAMED00818249015088 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
Category: Ankle/foot orthosis
Aspen M2 Afo, Posterior Left, Large by Aspen Medical Products, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 dd3aa0b8-b9a8-4f81-bcab-3dceba2d996a 61 fields · synced Oct 7, 2026
- EUDAMED 6ddb63e3-46f4-4198-9cff-02076e5f58eb 61 fields · synced May 17, 2026