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Splint Roll
EUDAMEDClass I (EU MDR)
Ref Splint Roll 50 x 11 Green/Grey rolledRef /Ref Splint Roll 50 x 11 Green/Grey foldedRef Splint Roll 5 x 11 Green/Grey Ref Splint Roll Set Yellow / Blue foldedRef Splint Roll 50 x 11 Yellow / Blue foldedRef Splint Roll 100 x 11 Yellow / Blue folded
Identity
- Trade Name
- Splint Roll EUDAMED
- Device Name
- First Aid Splint Roll EUDAMED
- Model / Reference
- Splint Roll 50 x 11 Green/Grey rolled EUDAMED/ EUDAMEDSplint Roll 50 x 11 Green/Grey folded EUDAMEDSplint Roll 5 x 11 Green/Grey EUDAMEDSplint Roll Set Yellow / Blue folded EUDAMEDSplint Roll 50 x 11 Yellow / Blue folded EUDAMEDSplint Roll 100 x 11 Yellow / Blue folded EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454796039 EUDAMED06951454779476 EUDAMED06951454763291 EUDAMED06951454752691 EUDAMED06951454794509 EUDAMED06951454755692 EUDAMED06951454740445 EUDAMED
- Basic UDI-DI
- 69514547325VE EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Roll by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69514547325VE | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (7)
- EUDAMED 2ad5c78b-3b6f-41b8-8c45-1aed462badb1 61 fields · synced Jul 30, 2026
- EUDAMED bdd064ad-c526-41ee-8c87-c9605044c971 61 fields · synced May 16, 2026
- EUDAMED 5cbc4261-266e-410a-a251-c379fc194681 61 fields · synced May 16, 2026
- EUDAMED 65cf99bd-8fd8-46db-9818-45d698d49464 61 fields · synced May 17, 2026
- EUDAMED 885302aa-11c5-4394-961c-9ddce2905f47 61 fields · synced May 19, 2026
- EUDAMED cfad79a6-ca9e-4501-9805-c27e1d20596f 61 fields · synced May 19, 2026
- EUDAMED 159eda15-853a-45a8-8c08-bdbca5b82db3 61 fields · synced May 19, 2026