Identity
- Trade Name
- Lower Limb Prosthesis Parts EUDAMED
- Device Name
- Lower Limb Prosthesis Parts EUDAMED
- Model / Reference
- 2SR2100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977272873097 EUDAMED
- Basic UDI-DI
- 697727287LLPP0001HU EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Lower Limb Prosthesis Parts by Fujian Guozi Rehabilitation Medical Co., Ltd — 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 | 697727287LLPP0001HU | Class I | Active |
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Manufacturer
- Manufacturer
- Fujian Guozi Rehabilitation Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000041764
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED 860658fb-513b-4fb4-bb2f-8c93c5f57d0e 61 fields · synced Oct 7, 2026