Identity
- Trade Name
- ADAPTER EUDAMED
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- AD-JC-FJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936603216361 EUDAMED
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06936603216361 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
Category: Gastro-urological guidewire, single-use
Adapter by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological guidewire, single-use.
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- Tracer Metro — COOK INCORPORATED · Class II
- Sterile Hydro-Slide Guidewire — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
- Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
- Optimos™ Guidewire — Taewoong Medical · Class II
- Single Use Endoscope Valves set — Anrei Medical (HZ) CO., LTD. · Class I
- CeroFrict® — SML Med-Tech Solutions Limited · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 762e920e-c89f-4329-9e80-d48e082c096b 61 fields · synced Oct 5, 2026