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Below elbow w limb build
EUDAMEDClass I (EU MDR)
Ref ASC27-LBModel ASC****Ref ASC27
Identity
- Trade Name
- Below elbow w limb build EUDAMEDBelow elbow EUDAMED
- Device Name
- High-Definition Custom Silicone EUDAMED
- Model / Reference
- ASC**** EUDAMEDASC27-LB EUDAMEDASC27 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50563496503714 EUDAMED50553482004400 EUDAMED
- Basic UDI-DI
- 50553482ASCTU EUDAMED
- EMDN Code
- Y061809 TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW) 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
Below elbow w limb build 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 | 50553482ASCTU | 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 (2)
- EUDAMED 23cc5b06-0226-4c0f-b803-265129e30d4e 61 fields · synced Jul 16, 2026
- EUDAMED 2c3da2bd-f825-4afd-a177-3c582fbc47e0 61 fields · synced May 18, 2026