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Splint
EUDAMEDClass I (EU MDR)
Ref N/AModel AN-401,AN-402,AN-403,AN-404,AN-405,AN-406,AN-407,AN-408,AN-409（or customized）
Identity
- Device Name
- Splint EUDAMED
- Model / Reference
- AN-401,AN-402,AN-403,AN-404,AN-405,AN-406,AN-407,AN-408,AN-409（or customized） EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975392694097 EUDAMED
- Basic UDI-DI
- 697539269ANSPTR EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Splint by Shenzhen Aonuo 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 Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697539269ANSPTR | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Aonuo Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038823
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 7a5cb94c-cb51-4cc9-b6a6-11b2ae6a562b 61 fields · synced Jun 19, 2026
- EUDAMED 7a5cb94c-cb51-4cc9-b6a6-11b2ae6a562b-1 61 fields · synced Jun 10, 2026