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Sterile gauze pads
EUDAMEDClass I (EU MDR)
Ref N/AModel 5*5CM/7.5*7.5CM/10*10CM
Identity
- Device Name
- Sterile gauze pads EUDAMED
- Model / Reference
- 5*5CM/7.5*7.5CM/10*10CM EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958689900085 EUDAMED16958689900078 EUDAMED
- Basic UDI-DI
- 69586899SGS00100017B EUDAMED
- EMDN Code
- M0202010101 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 gauze pads 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 | 69586899SGS00100017B | 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 (2)
- EUDAMED 64d599b7-7fad-45c0-a57f-99e7b8c42ddf 61 fields · synced Oct 6, 2026
- EUDAMED 101c1c44-56ac-43c2-aab7-14582e14ef0f 61 fields · synced May 19, 2026