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Left Medial – Auto Lock
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref C12693 510(k) K010477
Identity
- Trade Name
- Left Medial – Auto Lock EUDAMEDElbow FDA UDI
- Generic Name
- Body-powered elbow prosthesis, locking FDA UDI
- Device Name
- Body-powered elbow prosthesis, locking EUDAMED
- Model / Reference
- C12693 EUDAMEDLeft Medial – Auto Lock FDA UDI
Identifiers
- Catalog Number
- C12693 FDA UDI
- Primary DI / UDI-DI
- 50553482013310 EUDAMED05055348201331 FDA UDI
- Basic UDI-DI
- 50553482MEE00082 EUDAMED
- FDA Product Code
- IRD FDA UDI
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- Body-powered elbow prosthesis, locking FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Left Medial – Auto Lock by Hugh Steeper Limited — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010477 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 50553482MEE00082 | Class I | Active |
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Manufacturer
- Manufacturer
- Hugh Steeper Limited
- EUDAMED SRN
- GB-MF-000010196
- FDA Applicant
- Auto-Lock
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 096e8d9c-0020-4f8e-b33d-73e1faddc983 85 fields · synced Jun 19, 2026
- FDA UDI 68e5fbd3-98ad-4dbe-bb28-a5cc94a5b9af 33 fields · synced May 26, 2026
- FDA 510(k) K010477 1 fields · synced May 18, 2026