Identity
- Trade Name
- Dressing DIN 13 152-A (60 x 80 cm) EUDAMED
- Device Name
- Sterile Absorbent Nonwoven Compress EUDAMED
- Model / Reference
- 8010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975706487698 EUDAMED
- Basic UDI-DI
- 697570648110MW EUDAMED
- EMDN Code
- M0202030101 NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
Dressing DIN 13 152-A (60 x 80 cm) by Bestreat Safety & First Aid Solution 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 | 697570648110MW | 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 2185da92-327d-4705-924c-e4ec60e1b46e 61 fields · synced Jul 15, 2026