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Surgical kit
EUDAMEDClass I (EU MDR)
Ref L15607Model Surgical kit，1pc Surgical kit,6pcs/ctn Surgical kit，1pc Surgical kit，1pc Surgical kit，1pc Surgical kit，1pc Surgical kit，1pc Surgical Brush,1pc Surgical Brush,30ctn Surgical Brush,300ctn
Identity
- Device Name
- Surgical kit EUDAMED
- Model / Reference
- Surgical kit，1pc Surgical kit,6pcs/ctn Surgical kit，1pc Surgical kit，1pc Surgical kit，1pc Surgical kit，1pc Surgical kit，1pc Surgical Brush,1pc Surgical Brush,30ctn Surgical Brush,300ctn EUDAMEDL15607 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976594011149 EUDAMED
- Basic UDI-DI
- 697659401SK001MD EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Surgical kit by Anhui Promise Healthcare 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 | 697659401SK001MD | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Promise Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000039766
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 64ab009c-156a-4ab2-ad2d-94cf7a7b1772 61 fields · synced Jun 18, 2026