Identity
- Trade Name
- Perlon Cable Kit – Child EUDAMEDPerlon Cable Kit - Child EUDAMEDControl and Suspension Systems FDA UDI
- Generic Name
- Body-powered elbow prosthesis, locking FDA UDI
- Device Name
- Body-powered hand prosthesis EUDAMED
- Model / Reference
- C18378 EUDAMEDC18381 EUDAMEDPerlon Cable Kit - Child FDA UDI
Identifiers
- Catalog Number
- C18381 FDA UDI
- Primary DI / UDI-DI
- 50553482281788 EUDAMED50553482622888 EUDAMED05055348262288 FDA UDI
- Basic UDI-DI
- 50553482MEH0008P 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
Perlon Cable Kit – Child 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 | 50553482MEH0008P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hugh Steeper Limited
- EUDAMED SRN
- GB-MF-000010196
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 1aa9c0f6-50d6-4d7b-b86a-ea6e59574d36 61 fields · synced Jul 17, 2026
- EUDAMED 3a28cb7f-feb3-4580-a4fd-b2dace68eda8 61 fields · synced May 18, 2026
- FDA UDI 161aac20-0349-4ac8-805c-4fe82f98cfa0 33 fields · synced May 29, 2026