Identity
- Trade Name
- 50Hz ELECTRODE SEAL IN KIT EUDAMEDELECTRODE FDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Device Name
- Myoelectric hand prosthesis EUDAMED
- Model / Reference
- ELSK50 EUDAMED50Hz ELECTRODE SEAL IN KIT FDA UDI
Identifiers
- Catalog Number
- ELSK50 FDA UDI
- Primary DI / UDI-DI
- 50553482033288 EUDAMED05055348203328 FDA UDI
- Basic UDI-DI
- 50553482ELH0007U EUDAMED
- FDA Product Code
- IQZ FDA UDI
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
- GMDN Term
- Myoelectric hand 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
50Hz ELECTRODE SEAL IN KIT by Hugh Steeper Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 50553482ELH0007U | 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 f687e80f-df35-410a-95bd-8ecb50c6be6d 61 fields · synced Jun 19, 2026
- FDA UDI 00784fa5-6ace-40d7-ab1d-12f2d9d514e2 33 fields · synced May 30, 2026