All Silicone Sengstaken Blakemore Tube (Type32)
by Create Medic Co., Ltd. 2 variants
Ref 800 320 0210
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4542187000068X | Date3 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- All Silicone Sengstaken Blakemore Tube (Type32)All Silicone Sengstaken Blakemore Tube (Type 32)All Silicone Sengstaken Blakemore Tube(Type 32)
- Device Name
- All Silicone Sengstaken Blakemore Tube
- Model / Reference
- 800 320 0210
- Primary DI / UDI-DI
- 04542187228496, 04542187217780, 04542187242461, 04542187241136
- Basic UDI-DI
- 4542187000068X
- EMDN Code
- G010201 Sengstaken tubes
- Device Class
- Class IIa
- EU market of registration
- BulgariaBelgium
Manufacturer details
- EUDAMED SRN
- JP-MF-000010849
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Create Medic Co., Ltd.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No