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Single Use Sterile Cover

EUDAMED

Class I (EU MDR)

Ref 2.0Model 2.0,2.0LE,2.0PLUS

by TINAVI Medical Technologies Co., Ltd.

Identity

Trade Name
Single Use Sterile Cover EUDAMED
Device Name
Single Use Sterile Cover EUDAMED
Model / Reference
2.0,2.0LE,2.0PLUS EUDAMED
2.0 EUDAMED

Identifiers

Primary DI / UDI-DI
06971517000248 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

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Manufacturer

EUDAMED SRN
CN-MF-000021467
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (1)

  • EUDAMED 537dad6b-209a-445b-b13e-193d92f997a6 61 fields · synced Jun 19, 2026