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Disposable Drainage Catheter Kit
EUDAMEDClass IIa (EU MDR)
Ref DC-J083010Model DC-F model
Identity
- Device Name
- Disposable Drainage Catheter Kit EUDAMED
- Model / Reference
- DC-F model EUDAMEDDC-J083010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938016778849 EUDAMED
- Basic UDI-DI
- 693801670007GA EUDAMED
- EMDN Code
- A060201 EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Drainage Catheter Kit by Royal Fornia Medical Equipment 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 | 693801670007GA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Royal Fornia Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008628
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 940f7917-9c5c-4962-96ba-e648ea54d04f 61 fields · synced Oct 6, 2026