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Laparotomy Sponges with X-ray Detectable Thread
EUDAMEDClass IIa (EU MDR)
Ref UM-LSP-001-04
Identity
- Trade Name
- Laparotomy Sponges with X-ray Detectable Thread EUDAMED
- Device Name
- Laparotomy Sponges with X-ray Detectable Thread EUDAMED
- Model / Reference
- UM-LSP-001-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942495390041 EUDAMED
- Basic UDI-DI
- 697349085UMLPUL EUDAMED
- EMDN Code
- M0201030201 LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Laparotomy Sponges with X-ray Detectable Thread by Unimax Medical Products 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 | 697349085UMLPUL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000017381
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8cdc839f-1878-4216-9527-797a4b45f91c 61 fields · synced Jun 20, 2026