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PTCD Drainagekatheter Interne/Externe Anwendung
EUDAMEDClass IIb (EU MDR)
Ref 800-001-3796
Identity
- Trade Name
- PTCD Drainagekatheter Interne/Externe Anwendung EUDAMED
- Device Name
- PTCD Kit EUDAMED
- Model / Reference
- 800-001-3796 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187194654 EUDAMED
- Basic UDI-DI
- 4542187000158Y EUDAMED
- EMDN Code
- A060201 EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS) EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
PTCD Drainagekatheter Interne/Externe Anwendung by Create Medic Co., Ltd. — Class IIb — 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 | 4542187000158Y | Class IIb | 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 c747b5d8-c520-4f36-96f1-3910c46c2f2f 61 fields · synced Sep 18, 2026