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Medical Polymer Splint
EUDAMEDClass I (EU MDR)
Ref O-F01(120mm×195mm)Model O-F01(120mm×195mm),O-F02(165mm×195mm),O-F03(145mm×210mm),O-W01(185mm×310mm),O-W02(185mm×270mm),O-W03(280mm×300mm),O-W04(180mm×275mm),O-W05(205mm×300mm),O-W06(185mm×320mm),O-W07(240mm×600mm),O-H01(210mm×360mm),O-H02(190mm×340mm), etc
Identity
- Device Name
- Medical Polymer Splint EUDAMED
- Model / Reference
- O-F01(120mm×195mm),O-F02(165mm×195mm),O-F03(145mm×210mm),O-W01(185mm×310mm),O-W02(185mm×270mm),O-W03(280mm×300mm),O-W04(180mm×275mm),O-W05(205mm×300mm),O-W06(185mm×320mm),O-W07(240mm×600mm),O-H01(210mm×360mm),O-H02(190mm×340mm), etc EUDAMEDO-F01(120mm×195mm) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979319340012 EUDAMED
- Basic UDI-DI
- 697931934MPS001TU 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
Medical Polymer Splint by Shandong Huaxun 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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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 | 697931934MPS001TU | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Huaxun Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000050617
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 97f41ef0-84cb-4111-adc3-be4ece543305 61 fields · synced Jun 18, 2026