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Espire Elbow Classic Plus- Left- Caucasian- Medial Dial- Standard
EUDAMEDFDA UDIClass I (EU MDR)
Ref EECP-LCMD
Identity
- Trade Name
- Espire Elbow Classic Plus- Left- Caucasian- Medial Dial- Standard EUDAMEDESPIRE FDA UDI
- Generic Name
- Body-powered elbow prosthesis, locking FDA UDI
- Device Name
- Body-powered elbow prosthesis, locking EUDAMED
- Model / Reference
- EECP-LCMD EUDAMEDEspire Elbow Classic Plus- Left- Caucasian- Medial Dial- Standard FDA UDI
Identifiers
- Catalog Number
- EECP-LCMD FDA UDI
- Primary DI / UDI-DI
- 50563943264298 EUDAMED05056394326429 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
Espire Elbow Classic Plus- Left- Caucasian- Medial Dial- Standard 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 | 50553482MEE00082 | 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 cd9f5a16-e9e8-42c5-b780-7b32ee677da8 61 fields · synced Jun 19, 2026
- FDA UDI f438eadc-7d73-4825-943e-e3940c924f77 33 fields · synced May 30, 2026