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Medical Endoscope Image Processor
EUDAMEDClass IIa (EU MDR)
Ref /Model U7, U7 PRO, U7 EX, U7 SE, U7D, U7L, U7T, U7Q, U5, U5 PRO, U5 EX, U5 SE, U5D, U5L, U5T, U5Q
Identity
- Device Name
- Medical Endoscope Image Processor EUDAMED
- Model / Reference
- U7, U7 PRO, U7 EX, U7 SE, U7D, U7L, U7T, U7Q, U5, U5 PRO, U5 EX, U5 SE, U5D, U5L, U5T, U5Q EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802613771 EUDAMED
- Basic UDI-DI
- 69268026U7PRO000000000167 EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Medical Endoscope Image Processor by Medcaptain Medical Technology 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 | 69268026U7PRO000000000167 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 7f18aa65-556c-4c08-87c3-d59a898f0ee9 61 fields · synced Jul 21, 2026