Identity
- Trade Name
- Auxiliary Jet Adapter EUDAMED
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- AC03-221.O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970900854109 EUDAMED
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06970900854109 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Auxiliary Jet Adapter by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — 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 | 69709008510147Y | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 938b4d79-c34b-4348-a43d-526134a92606 61 fields · synced Jun 17, 2026