Identity
- Trade Name
- Transanale Dekompressionssonde Set EUDAMED
- Device Name
- Transanal Ileus Decompression Tube Set EUDAMED
- Model / Reference
- 002 380 0220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187142181 EUDAMED
- Basic UDI-DI
- 4542187000078Z EUDAMED
- EMDN Code
- G0301010501 COLONIC BALLOON CATHETERS, LOW PRESSURE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Transanale Dekompressionssonde Set 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 | 4542187000078Z | 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 (1)
- EUDAMED 66d1374a-30cd-48bb-9b00-2780aa6cbc80 61 fields · synced Jun 17, 2026