Identity
- Trade Name
- Aspen Ci Knee, S, Right EUDAMED
- Device Name
- KNEE EUDAMED
- Model / Reference
- 652006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818249014449 EUDAMED
- Basic UDI-DI
- 081824901KNEEAU EUDAMED
- EMDN Code
- Y061209 KNEE 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 Ci Knee, S, Right 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 | 081824901KNEEAU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aspen Medical Products, LLC
- EUDAMED SRN
- US-MF-000001571
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED b4cf5ed7-83b2-43d1-8706-55e95d877e9b 61 fields · synced Jul 28, 2026