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All Silicone Sengstaken Blakemore Tube (Type 52)
EUDAMEDClass IIa (EU MDR)
Ref 002 182 5218Ref 002-182-5218
Identity
- Trade Name
- All Silicone Sengstaken Blakemore Tube (Type 52) EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 002 182 5218 EUDAMED002-182-5218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187229011 EUDAMED04542187240818 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES 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 52) 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 (2)
- EUDAMED eb94a224-5fa3-4162-a3d3-b3a850437f5d 61 fields · synced Aug 4, 2026
- EUDAMED 59b56a29-a0e9-4446-ba4d-a131b9d0d9b5 61 fields · synced Jul 25, 2026