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Thermoplastic splint
EUDAMEDClass I (EU MDR)
Ref N/AModel Finger splint, Upper Limb Splint, Lower Limb Splint, Body splint
Identity
- Device Name
- Thermoplastic splint EUDAMED
- Model / Reference
- Finger splint, Upper Limb Splint, Lower Limb Splint, Body splint EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031553064 EUDAMED
- Basic UDI-DI
- 697303155TS002EA EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Hand/finger splint, reusable
Thermoplastic splint by Guangzhou Tian Hong Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697303155TS002EA | Class I | Unknown |
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Manufacturer
- Manufacturer
- Guangzhou Tian Hong Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008847
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ae1902a4-6b6a-4c72-a349-a841f83bd670 61 fields · synced Jun 19, 2026
- EUDAMED ae1902a4-6b6a-4c72-a349-a841f83bd670-1 61 fields · synced Jun 10, 2026