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Sterile Surgical and Care Kit
EUDAMEDClass IIa (EU MDR)
Ref MC3001Model A ,B,C,D,E,FModel A B C D E F
by Suzhou New Area Mingji Macromolecule Medical Apparatus Co., Ltd
Identity
- Device Name
- Sterile Surgical and Care Kit EUDAMED
- Model / Reference
- A ,B,C,D,E,F EUDAMEDMC3001 EUDAMEDA B C D E F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950570201519 EUDAMED
- Basic UDI-DI
- 695057022009EW EUDAMEDB-06950570201519 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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 Surgical and Care Kit by Suzhou New Area Mingji Macromolecule Medical Apparatus Co., Ltd — Class IIa — MDD, MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 695057022009EW | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 695057022009EW | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000037483
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED ab214eaf-90c1-4a9c-bae6-e084acf66361 61 fields · synced Oct 6, 2026
- EUDAMED 1282b022-2356-464d-818f-2570f6af4d60 61 fields · synced May 17, 2026