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Orthopedic Splint
EUDAMEDClass I (EU MDR)
Ref RSP645Model RSF312，RSF330，RSF335，RSF415，RSF418，RSF420，RSF430，RSF520，RSF525，RSF530，RSF545，RSF548，RSF630，RSF645，RSP312，RSP330，RSP335，RSP415，etcRef RRSP06Ref RSF545Ref RSF415Ref RSP545Ref RSF420Ref RRSF04Ref RSF520Ref RSF645Ref RSF530Ref RSP420Ref RRSP03Ref RSP530Ref RSP430Ref RSF330Ref RSP335Ref RRSP05Ref RRSF05Ref RRSF03Ref RSP418
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 EUDAMEDRSP645 EUDAMEDRRSP06 EUDAMEDRSF545 EUDAMEDRSF415 EUDAMEDRSP545 EUDAMEDRSF420 EUDAMEDRRSF04 EUDAMEDRSF520 EUDAMEDRSF645 EUDAMEDRSF530 EUDAMEDRSP420 EUDAMEDRRSP03 EUDAMEDRSP530 EUDAMEDRSP430 EUDAMEDRSF330 EUDAMEDRSP335 EUDAMEDRRSP05 EUDAMEDRRSF05 EUDAMEDRRSF03 EUDAMEDRSP418 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975627640288 EUDAMED06975627640387 EUDAMED06975627640110 EUDAMED06975627640042 EUDAMED06975627640257 EUDAMED06975627640066 EUDAMED06975627640318 EUDAMED06975627640080 EUDAMED06975627640141 EUDAMED06975627640103 EUDAMED06975627640202 EUDAMED06975627640356 EUDAMED06975627640240 EUDAMED06975627640219 EUDAMED06975627640028 EUDAMED06975627640172 EUDAMED06975627640370 EUDAMED06975627640325 EUDAMED06975627640301 EUDAMED06975627640196 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 (20)
- EUDAMED 32dbf3df-b0fc-49e4-b32f-86464ad1f3de 61 fields · synced Sep 17, 2026
- EUDAMED 690d60a6-e844-4e2c-8b79-1945ec0eba66 61 fields · synced May 16, 2026
- EUDAMED f19f9f24-4b19-403b-a7b2-cc3a8ceaa278 61 fields · synced May 16, 2026
- EUDAMED 2eed8903-725d-4c5a-8a9a-bc7957f2a0ab 61 fields · synced May 16, 2026
- EUDAMED bbe80ce2-130d-4bf0-beb5-221350755b35 61 fields · synced May 16, 2026
- EUDAMED f2927454-01c4-4bbd-89dc-8a4598b7f1fc 61 fields · synced May 17, 2026
- EUDAMED 2b177e34-4300-43b3-8a5c-39bf19e3c0da 61 fields · synced May 17, 2026
- EUDAMED 39d3d226-0a28-422b-b724-3ed79066e523 61 fields · synced May 17, 2026
- EUDAMED 6c38d9cd-5c93-4f71-b46f-8ded304aba72 61 fields · synced May 17, 2026
- EUDAMED 26691ee5-c95d-4157-8d87-499423966c2b 61 fields · synced May 17, 2026
- EUDAMED 3e2b4dec-d85e-495a-9fb0-c710eb7696b7 61 fields · synced May 17, 2026
- EUDAMED 3eaf5afa-ab7c-4f0b-a837-f0d7697dfe82 61 fields · synced May 18, 2026
- EUDAMED 59573ab1-4128-489c-be8e-7e2b7103652b 61 fields · synced May 18, 2026
- EUDAMED 7d5a53f2-0df9-40db-afa3-8f526aa8fe3d 61 fields · synced May 18, 2026
- EUDAMED c12b95cd-ffd0-490a-adc2-895b590ab231 61 fields · synced May 18, 2026
- EUDAMED 39f764df-7cfc-4b7d-ae8b-9e4a00519f31 61 fields · synced May 18, 2026
- EUDAMED 8acea2be-251a-46ca-b631-c2b3a35554cf 61 fields · synced May 18, 2026
- EUDAMED d2814845-110a-47e4-a344-b924de026e1b 61 fields · synced May 19, 2026
- EUDAMED dc9a802b-a9eb-42c9-9e3e-75d4b323150a 61 fields · synced May 19, 2026
- EUDAMED eeb37537-0f36-477c-836f-af95567cea17 61 fields · synced May 19, 2026