← Back to catalogue
Sonda Sengstaken Blakemore din silicon tip
EUDAMEDClass IIa (EU MDR)
Ref NS800 320 0210Ref NS800 320 0180Ref NS800 320 0160
Identity
- Trade Name
- Sonda Sengstaken Blakemore din silicon tip EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- NS800 320 0210 EUDAMEDNS800 320 0180 EUDAMEDNS800 320 0160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187216592 EUDAMED04542187216585 EUDAMED04542187216578 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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 din silicon tip 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Create Medic Co., Ltd.
- EUDAMED SRN
- JP-MF-000010849
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 3d30b0b8-066f-414d-9e63-c958cd689b9d 61 fields · synced Jul 15, 2026
- EUDAMED b7854215-613a-43b0-83f0-41ecfe92a6de 61 fields · synced May 17, 2026
- EUDAMED 5351e299-2345-4e0e-8695-d7878921794d 61 fields · synced May 18, 2026