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All Silicone Sengstaken Blakemore Tube (Type 32 +2 more)

EUDAMED

Class IIa (EU MDR)

Ref 800 001 7198

by Create Medic Co., Ltd.

Identity

Trade Name
All Silicone Sengstaken Blakemore Tube (Type 32, W/O Stylet) EUDAMED
Device Name
All Silicone Sengstaken Blakemore Tube EUDAMED
Model / Reference
800 001 7198 EUDAMED

Identifiers

Primary DI / UDI-DI
04542187228649 EUDAMED
Basic UDI-DI
4542187000068X EUDAMED
EMDN Code
G010201 SENGSTAKEN TUBES EUDAMED
Models / Variants
Type 32 EUDAMED
W EUDAMED
O Stylet EUDAMED

Classification

Device Class
Class IIa 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

All Silicone Sengstaken Blakemore Tube (Type 32 +2 more) by Create Medic Co., Ltd. — Class IIa — MDR — listed in EUDAMED — 3 models

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Create Medic Co., Ltd.
EUDAMED SRN
JP-MF-000010849
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1)

  • EUDAMED 37f7fd65-3baa-44c7-a1b9-e385c55e7019 61 fields · synced Oct 6, 2026