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Bougie

EUDAMED

Class I (EU MDR)

Ref 000946Model Straight, Paediatric; Straight, Adult; Angled (coudé), Adult; Straight, Hollow; Angled, Hollow; Pre-lubricated articulating introducer with intuitive colored depth systemRef 001181

by Tianjin Medis Medical Device Co., Ltd.

Identity

Trade Name
Bougie EUDAMED
Bougies EUDAMED
Device Name
Bougie EUDAMED
Model / Reference
Straight, Paediatric; Straight, Adult; Angled (coudé), Adult; Straight, Hollow; Angled, Hollow; Pre-lubricated articulating introducer with intuitive colored depth system EUDAMED
000946 EUDAMED
001181 EUDAMED

Identifiers

Primary DI / UDI-DI
06920687351056 EUDAMED
06920687351339 EUDAMED
Basic UDI-DI
69206873BG001FU EUDAMED
Direct Marketing DI
06920687351056 EUDAMED
EMDN Code
R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED
Italy 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

Bougie by Tianjin Medis Medical Device 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

Manufacturer
Tianjin Medis Medical Device Co., Ltd.
EUDAMED SRN
CN-MF-000020126
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED a770747b-33a6-4531-8c65-1e476ed56be1 61 fields · synced Oct 6, 2026
  • EUDAMED 504ae841-43d5-4c22-8783-775bd1e47963 61 fields · synced Aug 1, 2026