← Back to catalogue
Blakemore-Sengstakenova sonda zo 100％ silikónu（Typ 32，Bez mandrénu）
EUDAMEDClass IIa (EU MDR)
Ref 802 320 0180Ref 800 320 0140
Identity
- Trade Name
- Blakemore-Sengstakenova sonda zo 100％ silikónu（Typ 32，Bez mandrénu） EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 802 320 0180 EUDAMED800 320 0140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187245141 EUDAMED04542187245127 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia 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
Blakemore-Sengstakenova sonda zo 100％ silikónu（Typ 32，Bez mandrénu） by Create Medic Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 (2)
- EUDAMED 4d4f9047-bc7f-4605-b75d-fd815fd9b851 61 fields · synced Oct 6, 2026
- EUDAMED df41a168-9275-4741-9c08-0be9daf07f6e 61 fields · synced May 19, 2026