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All Silicone Sengstaken Blakemore Tube (Type-42)
EUDAMEDClass IIa (EU MDR)
Ref 002-182-0440Ref 002 182 0440Ref 002-182-0420Ref 002-182-0400Ref 002 182 0400Ref 002 182 0420
Identity
- Trade Name
- All Silicone Sengstaken Blakemore Tube (Type-42) EUDAMEDAll Silicone Sengstaken Blakemore Tube (Type 42) EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 002-182-0440 EUDAMED002 182 0440 EUDAMED002-182-0420 EUDAMED002-182-0400 EUDAMED002 182 0400 EUDAMED002 182 0420 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187188127 EUDAMED04542187240955 EUDAMED04542187177770 EUDAMED04542187188103 EUDAMED04542187228984 EUDAMED04542187228045 EUDAMED04542187240177 EUDAMED04542187188110 EUDAMED04542187240184 EUDAMED04542187177763 EUDAMED04542187228052 EUDAMED04542187225679 EUDAMED04542187240191 EUDAMED04542187219012 EUDAMED04542187219029 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMEDMalta 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-42) 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 (15)
- EUDAMED 026d444a-fe13-453f-91c4-7bfd05b90577 61 fields · synced Oct 5, 2026
- EUDAMED 0e58ffb1-6a49-4291-986b-9962da98d4dd 61 fields · synced May 17, 2026
- EUDAMED 1276e42f-4eac-4572-81da-77a8fcf55f2e 61 fields · synced May 17, 2026
- EUDAMED e5b0cdc2-177e-4443-a6ce-ef6838d92824 61 fields · synced May 17, 2026
- EUDAMED 85badb47-c1aa-4b84-bd07-6dc7bad7f3c6 61 fields · synced May 19, 2026
- EUDAMED 6e513dbd-df64-45e5-9090-80973df01c81 61 fields · synced May 19, 2026
- EUDAMED 059224cb-e595-43d5-95a0-1616ac49e0d8 61 fields · synced May 19, 2026
- EUDAMED aae81a7c-7cb1-4fae-9b59-a4328602af28 61 fields · synced May 19, 2026
- EUDAMED 8265679c-6fb7-48fd-b850-d7051956883b 61 fields · synced May 19, 2026
- EUDAMED d9ccd8e2-2cf9-466e-8241-a870feac6344 61 fields · synced May 19, 2026
- EUDAMED f24140c1-24ec-4663-8854-31448588427b 61 fields · synced May 19, 2026
- EUDAMED b0ced2fe-8718-4ca3-885e-3a708cd003a4 61 fields · synced May 19, 2026
- EUDAMED e5a2384b-8b90-45c1-bba6-cea000a244d6 61 fields · synced May 19, 2026
- EUDAMED 73ef3d62-07fb-4408-a1cb-6fb58cf10c53 61 fields · synced Jul 10, 2026
- EUDAMED 36d2f954-3de3-4b37-9479-60ec821d6143 61 fields · synced Jul 22, 2026