Identity
- Trade Name
- SPLIT TF SKIN+ 22/23 RT L E14 EUDAMED
- Device Name
- External limb prosthesis finishing component, non-customized EUDAMED
- Model / Reference
- TLC22RL/E14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055348230607 EUDAMED
- Basic UDI-DI
- 50553482COS000AG EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER 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
Split Tf Skin+ 22/23 Rt L E14 by Hugh Steeper Limited — 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 | 50553482COS000AG | Class I | Active |
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Manufacturer
- Manufacturer
- Hugh Steeper Limited
- EUDAMED SRN
- GB-MF-000010196
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED bd9a8add-1ce2-48ad-a9de-2f9d0bf9a5d5 61 fields · synced Jun 20, 2026