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Seesheen
EUDAMEDClass IIa (EU MDR)
Ref HP-1315 pro2Model HP-1315、HP-1315 pro、HP-1315 pro2、HP-1315 pro3
Identity
- Trade Name
- SEESHEEN EUDAMED
- Device Name
- Imaging System EUDAMED
- Model / Reference
- HP-1315、HP-1315 pro、HP-1315 pro2、HP-1315 pro3 EUDAMEDHP-1315 pro2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970680131612 EUDAMED
- Basic UDI-DI
- 69706801317IMA6J EUDAMED
- Direct Marketing DI
- 06970680131612 EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Seesheen by Zhuhai Seesheen Medical Technology Co., Ltd. — Class IIa — CE/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 | 69706801317IMA6J | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Seesheen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027274
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f0a11857-df66-4f0a-9d8b-196f5c623f28 61 fields · synced Oct 7, 2026