Identity
- Trade Name
- TEHLIN FDA UDI
- Generic Name
- Partial-hand prosthesis FDA UDI
- Device Name
- FUNCTIONAL PALM (LEFT/LARGE) EUDAMEDFDA UDI
- Model / Reference
- J-HT-002L EUDAMEDFDA UDI
- Description
- FUNCTIONAL PALM (LEFT/LARGE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719883463524 EUDAMEDFDA UDI
- Basic UDI-DI
- 41798834602208L EUDAMED
- FDA Product Code
- IRA FDA UDI
- EMDN Code
- Y061809 TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW) EUDAMED
- GMDN Term
- Partial-hand prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Category: Partial-hand prosthesis
Tehlin by Teh Lin Prosthetic & Orthopaedic, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Partial-hand prosthesis.
- TEHLIN — Teh Lin Prosthetic & Orthopaedic, Inc. · Class I
- TEHLIN — Teh Lin Prosthetic & Orthopaedic, Inc. · Class I
- TEHLIN — Teh Lin Prosthetic & Orthopaedic, Inc. · Class I
- TEHLIN — Teh Lin Prosthetic & Orthopaedic, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Teh Lin Prosthetic & Orthopaedic, Inc.
Sources (2)
- FDA UDI edaa135a-6686-4235-882b-bd2830b9f5dc 33 fields · synced Jul 8, 2026
- EUDAMED f58461b7-a510-4336-b4a7-dd46f71f04a2 61 fields · synced Jul 8, 2026