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Sengstaken Blakemore Sonde (Typ 42)
EUDAMEDClass IIa (EU MDR)
Ref 002 182 0420Ref 002 182 0400Ref 002 182 0440
Identity
- Trade Name
- Sengstaken Blakemore Sonde (Typ 42) EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 002 182 0420 EUDAMED002 182 0400 EUDAMED002 182 0440 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187228403 EUDAMED04542187228397 EUDAMED04542187228410 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Sengstaken Blakemore Sonde (Typ 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 fc4d5262-f77d-490c-a296-d221d30f9b9e 61 fields · synced Jul 15, 2026
- EUDAMED e24790e6-e151-41ee-9123-c5536de5260f 61 fields · synced May 18, 2026
- EUDAMED 2e42adfe-5c96-4eaa-bc00-6dd46e71cee2 61 fields · synced May 18, 2026