← Back to catalogue
Thermoplastics
EUDAMEDClass I (EU MDR)
Ref N/AModel Head and Neck and Shoulder sheets, Head Only sheets, Body sheetsModel Classic
Identity
- Device Name
- Thermoplastics EUDAMEDThermoplastic sheet EUDAMED
- Model / Reference
- Head and Neck and Shoulder sheets, Head Only sheets, Body sheets EUDAMEDN/A EUDAMEDClassic EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031556836 EUDAMED06980106570024 EUDAMED06980106570017 EUDAMED
- Basic UDI-DI
- 697303155NSS500HX EUDAMED69801065TSC001NJ EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDAustria EUDAMEDTürkiye 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
Thermoplastics by Guangzhou Tian Hong Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
- Elastic Bandage — Anji Xinyuan Medical Supplies Co.,Ltd. · Class I
- Plastalume — BROWNMED, INC. · Class I
- Splint — Anping Guardian Medical Equipment Co., Ltd · Class I
- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- MedTextile — Medtex Swiss Ltd · Class I
- 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 | 697303155NSS500HX | Class I | Unknown |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangzhou Tian Hong Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008847
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED f7cffa73-8013-45fe-9a09-0c7a69c12823 61 fields · synced Jul 14, 2026
- EUDAMED f7cffa73-8013-45fe-9a09-0c7a69c12823-1 61 fields · synced Jun 10, 2026
- EUDAMED 92eecf06-be03-4adf-aa6c-af92ecfa886c 61 fields · synced Jul 10, 2026
- EUDAMED 3e5fb705-1adc-49b9-837c-d7792e9ebe6c 61 fields · synced Jul 11, 2026