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Sonde de Sengstaken Blakemore en Silicone（Type 32）
EUDAMEDClass IIa (EU MDR)
Ref 800 320 0180Ref 800 320 0150Ref 800 320 0210Ref 800 320 0160
Identity
- Trade Name
- Sonde de Sengstaken Blakemore en Silicone（Type 32） EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 800 320 0180 EUDAMED800 320 0150 EUDAMED800 320 0210 EUDAMED800 320 0160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187241334 EUDAMED04542187241310 EUDAMED04542187241341 EUDAMED04542187241327 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Sonde de Sengstaken Blakemore en Silicone（Type 32） 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 (4)
- EUDAMED 2c799ac2-8407-4b6e-893d-cfed8dda3f15 61 fields · synced Jul 21, 2026
- EUDAMED d4e1c45e-dddc-4e77-a670-4e36032933dd 61 fields · synced May 17, 2026
- EUDAMED 6f6ab58d-49bb-44d2-be99-65620da7f9a4 61 fields · synced May 18, 2026
- EUDAMED c80cde73-31b4-4f42-97a5-7745f872ade5 61 fields · synced May 19, 2026