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Orthopedic Splint
EUDAMEDClass I (EU MDR)
Ref RRSP02Model RSF312，RSF330，RSF335，RSF415，RSF418，RSF420，RSF430，RSF520，RSF525，RSF530，RSF545，RSF548，RSF630，RSF645，RSP312，RSP330，RSP335，RSP415，etc
Identity
- Trade Name
- Orthopedic Splint EUDAMED
- Device Name
- Orthopedic Splint EUDAMED
- Model / Reference
- RSF312，RSF330，RSF335，RSF415，RSF418，RSF420，RSF430，RSF520，RSF525，RSF530，RSF545，RSF548，RSF630，RSF645，RSP312，RSP330，RSP335，RSP415，etc EUDAMEDRRSP02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975627640349 EUDAMED
- Basic UDI-DI
- 697562764OS001NU 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
Orthopedic Splint by JiangSu Reliable Medical Device Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697562764OS001NU | Class I | Active |
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Manufacturer
- Manufacturer
- JiangSu Reliable Medical Device Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000049314
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f3cdce45-e24c-48fb-84e7-b83bad1e3495 61 fields · synced Jun 19, 2026