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Image intensifier cover, round 90 cm
EUDAMEDClass I (EU MDR)
Ref SDV16-10Model Equipment Cover
Identity
- Trade Name
- Image intensifier cover, round 90 cm EUDAMED
- Device Name
- Type D Equipment Cover EUDAMED
- Model / Reference
- Equipment Cover EUDAMEDSDV16-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288683104 EUDAMED
- Basic UDI-DI
- 69562886XA0004QX EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT 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
Category: Vascular booties
Image intensifier cover, round 90 cm by Cobes Industries(Hefei) Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69562886XA0004QX | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0adaac03-2ea4-42e7-87f9-9218d185f0f8 61 fields · synced Jul 9, 2026