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Sonda Sengstaken Blakemore (Tipo 42)
EUDAMEDClass IIa (EU MDR)
Ref 002 182 0440Ref 002-182-0400Ref 002-182-0440
Identity
- Trade Name
- Sonda Sengstaken Blakemore (Tipo 42) EUDAMEDSonda de Sengstaken-Blakemore em Silicone (Tipo 42) EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 002 182 0440 EUDAMED002-182-0400 EUDAMED002-182-0440 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187240580 EUDAMED04542187165401 EUDAMED04542187165425 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDPortugal 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
Sonda Sengstaken Blakemore (Tipo 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 (3)
- EUDAMED 5f3da1f5-7b8b-4fba-bb2c-6a010cd2545d 61 fields · synced Aug 2, 2026
- EUDAMED 4de079dd-3b88-42bd-90f3-02ba02e809da 61 fields · synced May 18, 2026
- EUDAMED bb4fce81-8c61-4838-b2a6-c00b51b2b0c0 61 fields · synced May 18, 2026