Identity
- Device Name
- Gauze roll EUDAMED
- Model / Reference
- 5*450CM/7.5*450CM EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958689900429 EUDAMED
- Basic UDI-DI
- 69586899GR00100017B EUDAMED
- EMDN Code
- M030101 HYDROPHILIC GAUZE BANDAGES 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
Gauze roll by Pujiang Jianyu Sanitary 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 | 69586899GR00100017B | Class I | Active |
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Manufacturer
- Manufacturer
- Pujiang Jianyu Sanitary Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000043742
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6fdebea9-654f-480a-9d4d-4d738d70da3a 61 fields · synced Jun 18, 2026