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Fixative Bandages DIN 61 634 - FB 8 (8 cm x 4 m)
EUDAMEDClass I (EU MDR)
Ref 2022
Identity
- Trade Name
- Fixative Bandages DIN 61 634 - FB 8 (8 cm x 4 m) EUDAMED
- Device Name
- Elastic Bandage EUDAMED
- Model / Reference
- 2022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975706487728 EUDAMED
- Basic UDI-DI
- 697570648117NC EUDAMED
- EMDN Code
- M0303010101 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Fixative Bandages DIN 61 634 - FB 8 (8 cm x 4 m) by Bestreat Safety & First Aid Solution Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 697570648117NC | Class I | Active |
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Manufacturer
- Manufacturer
- Bestreat Safety & First Aid Solution Co., Ltd.
- EUDAMED SRN
- CN-MF-000029564
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 647e05ff-a96f-45d7-832e-2046e525fe31 61 fields · synced Jul 9, 2026