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Bandage
EUDAMEDClass I (EU MDR)
Ref Emergency Bandage CG-B1Model Emergency Bandage CG-B1, First Aid Bandage CG-B2, Conforming Pressure Bandage CG-B3, Gauze Bandage CG-B4
Identity
- Device Name
- Bandage EUDAMED
- Model / Reference
- Emergency Bandage CG-B1, First Aid Bandage CG-B2, Conforming Pressure Bandage CG-B3, Gauze Bandage CG-B4 EUDAMEDEmergency Bandage CG-B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945367102001 EUDAMED
- Basic UDI-DI
- 69453671BandageTS EUDAMED
- EMDN Code
- M0303010101 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION 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
Bandage by Qingdao Biotemed Biomaterials 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 | 69453671BandageTS | Class I | Active |
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Manufacturer
- Manufacturer
- Qingdao Biotemed Biomaterials Co., Ltd.
- EUDAMED SRN
- CN-MF-000052115
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 399fda48-724d-44cb-9674-78028651b153 61 fields · synced Oct 6, 2026