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Single Use Sterile Cover
EUDAMEDClass I (EU MDR)
Ref 2.0 PLUSModel 2.0，2.0LE，2.0PLUS
Identity
- Trade Name
- Single Use Sterile Cover EUDAMED
- Device Name
- Single Use Sterile Cover EUDAMED
- Model / Reference
- 2.0，2.0LE，2.0PLUS EUDAMED2.0 PLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971517000255 EUDAMED
- Basic UDI-DI
- 697151700018FZ EUDAMED
- EMDN Code
- T030299 ROBOTIC SURGERY COVERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Single Use Sterile Cover by TINAVI Medical Technologies 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 | 697151700018FZ | Class I | Active |
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Manufacturer
- Manufacturer
- TINAVI Medical Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000021467
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED e2b1ea84-a871-4528-a365-fb708971d0a8 61 fields · synced Jun 17, 2026