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Espire Elbow Pro- Left- Black Carbon Finish- Small- COAPT
EUDAMEDFDA UDIClass I (EU MDR)
Ref EEP-L001S-CO
Identity
- Trade Name
- Espire Elbow Pro- Left- Black Carbon Finish- Small- COAPT EUDAMEDESPIRE FDA UDI
- Generic Name
- Electrical elbow prosthesis FDA UDI
- Device Name
- Electrical elbow prosthesis EUDAMED
- Model / Reference
- EEP-L001S-CO EUDAMEDEspire Elbow Pro- Left- Black Carbon Finish- Small- COAPT FDA UDI
Identifiers
- Catalog Number
- EEP-L001S-CO FDA UDI
- Primary DI / UDI-DI
- 50563943280892 EUDAMED05056394328089 FDA UDI
- Basic UDI-DI
- 50553482ELE00077 EUDAMED
- 510(k) Number
- K182757 FDA UDI
- FDA Product Code
- IRE FDA UDI
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- Electrical elbow prosthesis 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Espire Elbow Pro- Left- Black Carbon Finish- Small- COAPT by Hugh Steeper Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50553482ELE00077 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 a4c30dc3-707f-4358-9ae2-55182f201467 61 fields · synced Jul 26, 2026
- FDA UDI b2b9cd3e-75f7-47a5-a871-14a0c83d5c25 34 fields · synced May 30, 2026