Identity
- Device Name
- Disposable Surgical Kits EUDAMED
- Model / Reference
- II EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974274161924 EUDAMED
- Basic UDI-DI
- 697427416DSK002JH EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Disposable Surgical Kits by Anhui Monique Medical Materials 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 | 697427416DSK002JH | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Monique Medical Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000001162
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d49e3ccd-7a67-42a2-8c2f-e4879f219a27 61 fields · synced Jun 19, 2026