Identity
- Trade Name
- Lap Sponge X-RAY thread and loop EUDAMED
- Device Name
- LAP SPONGES EUDAMED
- Model / Reference
- MAC5030NA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977231817803 EUDAMED
- Basic UDI-DI
- 697240330LS0000019D EUDAMED
- EMDN Code
- M0201030202 LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Lap Sponge X-RAY thread and loop 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 365be373-7ca9-48df-84c1-80ebc985fa50 61 fields · synced Oct 6, 2026