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Sengstaken Blakemore Sonde aus Silikon (Typ42)
EUDAMEDClass IIa (EU MDR)
Ref 002-182-0420Ref 002-182-0440Ref 002-182-0400
Identity
- Trade Name
- Sengstaken Blakemore Sonde aus Silikon (Typ42) EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 002-182-0420 EUDAMED002-182-0440 EUDAMED002-182-0400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187162196 EUDAMED04542187162202 EUDAMED04542187162189 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 aus Silikon (Typ42) 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 a1afa31a-4df2-42b1-a595-2a735891aeef 61 fields · synced Aug 2, 2026
- EUDAMED b250b864-3843-4911-a7eb-cd028ddbc117 61 fields · synced May 18, 2026
- EUDAMED d986abb3-f91c-4036-a167-cf294f842926 61 fields · synced May 19, 2026