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Gauze sponges 12-ply STERILE DOUBLE PACKED
EUDAMEDClass IIa (EU MDR)
Ref 520015
Identity
- Trade Name
- Gauze sponges 12-ply STERILE DOUBLE PACKED EUDAMED
- Device Name
- LAP SPONGES EUDAMED
- Model / Reference
- 520015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260348614628 EUDAMED
- Basic UDI-DI
- 697240330LS0000019D EUDAMED
- EMDN Code
- M0201030201 LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Gauze sponges 12-ply STERILE DOUBLE PACKED by Xuchang Zhende Surgical Dressing Co., Ltd. — Class IIa — 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 | 697240330LS0000019D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xuchang Zhende Surgical Dressing Co., Ltd
- EUDAMED SRN
- CN-MF-000009222
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c0516ecd-3fb6-4bce-9dbb-7b34a810b6e5 61 fields · synced Jul 9, 2026