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Sterile Hydrophilic Gauze Bandages
EUDAMEDClass I (EU MDR)
Ref GR8500BIOModel Hydrophilic gauze
Identity
- Trade Name
- STERILE HYDROPHILIC GAUZE BANDAGES EUDAMED
- Device Name
- Hydrophilic gauze bandage EUDAMED
- Model / Reference
- Hydrophilic gauze EUDAMEDGR8500BIO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938056233452 EUDAMED
- Basic UDI-DI
- 69380562MB007L4 EUDAMED
- EMDN Code
- M030101 HYDROPHILIC GAUZE BANDAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
Sterile Hydrophilic Gauze Bandages by Zhejiang Hongyu Medical Commodity 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 | 69380562MB007L4 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Hongyu Medical Commodity Co., Ltd
- EUDAMED SRN
- CN-MF-000008204
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED cf6fe877-87f8-47a1-a40c-fb667c0cca2b 61 fields · synced Jul 30, 2026