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Espire Elbow Hybrid- Right- Black Carbon Finish- Medial Dial- Small- COAPT
EUDAMEDClass I (EU MDR)
Ref EEH-R001MS-CORef EEH-R001MS
Identity
- Trade Name
- Espire Elbow Hybrid- Right- Black Carbon Finish- Medial Dial- Small- COAPT EUDAMEDEspire Elbow Hybrid- Right- Black Carbon Finish- Medial Dial- Small EUDAMED
- Device Name
- Electrical elbow prosthesis EUDAMED
- Model / Reference
- EEH-R001MS-CO EUDAMEDEEH-R001MS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50563943276178 EUDAMED50563943276000 EUDAMED
- Basic UDI-DI
- 50553482ELE00077 EUDAMED
- EMDN Code
- Y061899 UPPER 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
Espire Elbow Hybrid- Right- Black Carbon Finish- Medial Dial- Small- COAPT by Hugh Steeper Limited — Class I — MDR — listed in EUDAMED
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 | 50553482ELE00077 | 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 748d48fb-a02e-45d1-bd59-accf4767b3b2 61 fields · synced Oct 6, 2026
- EUDAMED 48788b49-a995-46bd-86de-38e73dcf06be 61 fields · synced May 17, 2026