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All Silicone Sengstaken Blakemore Tube (Type 32)
EUDAMEDClass IIa (EU MDR)
Ref 800 320 0180Ref 800 320 0160Ref 800 320 0210Ref 800 320 0140Ref 800 320 0150Ref 800-320-0210Ref 800-320-0140
Identity
- Trade Name
- All Silicone Sengstaken Blakemore Tube (Type 32) EUDAMEDAll Silicone Sengstaken Blakemore Tube (Type32) EUDAMEDAll Silicone Sengstaken Blakemore Tube (Type-32) EUDAMEDAll Silicone Sengstaken Blakemore Tube（Type 32） EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 800 320 0180 EUDAMED800 320 0160 EUDAMED800 320 0210 EUDAMED800 320 0140 EUDAMED800 320 0150 EUDAMED800-320-0210 EUDAMED800-320-0140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187212204 EUDAMED04542187217766 EUDAMED04542187228496 EUDAMED04542187212174 EUDAMED04542187217742 EUDAMED04542187228946 EUDAMED04542187195019 EUDAMED04542187242454 EUDAMED04542187242447 EUDAMED04542187217780 EUDAMED04542187194975 EUDAMED04542187242461 EUDAMED04542187217773 EUDAMED04542187241136 EUDAMED04542187212198 EUDAMED04542187242430 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMEDBelgium 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) by Create Medic Co., Ltd. — Class IIa — 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 | 4542187000068X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Create Medic Co., Ltd.
- EUDAMED SRN
- JP-MF-000010849
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (16)
- EUDAMED 0cbe9482-9e0f-43e6-9530-a9f81be3b0a0 61 fields · synced Oct 5, 2026
- EUDAMED 3b6f9a18-6908-40ed-b8a6-e594e7071e01 61 fields · synced May 17, 2026
- EUDAMED 99e2ce71-295c-4ecf-bca7-9a42f47ddd15 61 fields · synced May 17, 2026
- EUDAMED 6dd34d23-895c-44dd-a82c-a1af691b1b93 61 fields · synced May 17, 2026
- EUDAMED f0c85d1f-8f06-4811-8d63-97e576bbb7c2 61 fields · synced May 17, 2026
- EUDAMED 3fa09aeb-e9f5-439d-b637-c3ff979df27d 61 fields · synced May 18, 2026
- EUDAMED f8e984c1-6628-4932-97b4-4d2f9780dcf7 61 fields · synced May 18, 2026
- EUDAMED 2d96eba0-9c97-423f-bfaa-185d43746971 61 fields · synced May 18, 2026
- EUDAMED f6ec9e1d-648e-407b-9990-6924ee866898 61 fields · synced May 18, 2026
- EUDAMED ed177ef4-5584-47e9-b351-d07ee7bb2481 61 fields · synced May 19, 2026
- EUDAMED 6c2bb9c7-2dc5-476a-8319-0443e9b71172 61 fields · synced May 19, 2026
- EUDAMED e53a1c9a-f810-4b1a-9f9f-0b0b8d3152d5 61 fields · synced May 19, 2026
- EUDAMED 581d789c-9381-4124-a5b1-72cc5d0bce1c 61 fields · synced May 19, 2026
- EUDAMED b9784ef8-8d5b-4e1d-943e-77619f199648 61 fields · synced May 19, 2026
- EUDAMED 7fa45532-2cc1-4282-87ca-824cb852419e 61 fields · synced May 19, 2026
- EUDAMED 9dac7da4-f24a-4725-9e08-118febc857b1 61 fields · synced May 19, 2026