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All Silicone Sengstaken Blakemore Tube (Type32 +2 more)
EUDAMEDClass IIa (EU MDR)
Ref 800 001 7186Ref 800 001 7187Ref 800 320 0210Ref 800 320 0140Ref 800 320 0160Ref 800 001 7185Ref 800 001 7184
Identity
- Trade Name
- All Silicone Sengstaken Blakemore Tube (Type32, W/O Stylet) EUDAMEDAll Silicone Sengstaken Blakemore Tube (Type32) EUDAMED
- Device Name
- All Silicone Sengstaken Blakemore Tube EUDAMED
- Model / Reference
- 800 001 7186 EUDAMED800 001 7187 EUDAMED800 320 0210 EUDAMED800 320 0140 EUDAMED800 320 0160 EUDAMED800 001 7185 EUDAMED800 001 7184 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187228526 EUDAMED04542187228533 EUDAMED04542187240894 EUDAMED04542187240856 EUDAMED04542187240870 EUDAMED04542187228519 EUDAMED04542187228502 EUDAMED04542187228472 EUDAMED04542187228465 EUDAMED
- Basic UDI-DI
- 4542187000068X EUDAMED
- EMDN Code
- G010201 SENGSTAKEN TUBES EUDAMED
Classification
- Device Class
- Class IIa 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
All Silicone Sengstaken Blakemore Tube (Type32 +2 more) by Create Medic Co., Ltd. — Class IIa — MDR — listed in EUDAMED — 3 models
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 (9)
- EUDAMED f5369b8e-bde6-4d31-8d38-ec1408caf5e9 61 fields · synced Oct 6, 2026
- EUDAMED 75f6710e-f1ad-49cc-935d-60375844a178 61 fields · synced May 16, 2026
- EUDAMED 7f965eb5-e056-48eb-bccd-6aee102a9aa8 61 fields · synced May 17, 2026
- EUDAMED b0eebd1c-530a-4297-a7c9-270ee1f3f87e 61 fields · synced May 17, 2026
- EUDAMED 9fc9066f-b8c7-464a-a925-7686c0dcd007 61 fields · synced May 18, 2026
- EUDAMED 23565972-7177-4976-8a48-2a9c06e0319e 61 fields · synced May 18, 2026
- EUDAMED 02d4b3ac-3a43-41bc-a31e-ded59d9254d7 61 fields · synced May 18, 2026
- EUDAMED 736d3744-bd71-46d6-a45f-0a1853834913 61 fields · synced May 18, 2026
- EUDAMED 798630fd-d901-47ed-98fa-e241c78eaf82 61 fields · synced May 18, 2026