Identity
- Device Name
- Transparent Dressing EUDAMED
- Model / Reference
- B1020S 10cm×20cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971623095978 EUDAMED
- Basic UDI-DI
- 697162309FLYW EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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
Transparent Dressing by Zibo Qichuang Medical products 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 | 697162309FLYW | Class I | Active |
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Manufacturer
- Manufacturer
- Zibo Qichuang Medical products Co., Ltd
- EUDAMED SRN
- CN-MF-000026477
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED dfdb1604-6753-41ba-aaec-93e1368dc520 61 fields · synced Jun 19, 2026