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neopiston®
EUDAMEDClass I (EU MDR)
Ref 222489Ref 222424Ref 222627Ref 222628Ref 222645Ref 222423Ref 222492Ref 222485Ref 222421Ref 222416Ref 222413Ref 222415Ref 222414Ref 222411
Identity
- Trade Name
- neopiston® EUDAMED
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- 222489 EUDAMED222424 EUDAMED222627 EUDAMED222628 EUDAMED222645 EUDAMED222423 EUDAMED222492 EUDAMED222485 EUDAMED222421 EUDAMED222416 EUDAMED222413 EUDAMED222415 EUDAMED222414 EUDAMED222411 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970900852501 EUDAMED06970900852310 EUDAMED06970900859104 EUDAMED06970900859050 EUDAMED06936603203972 EUDAMED06970900852303 EUDAMED06970900852549 EUDAMED06970900852464 EUDAMED06970900852280 EUDAMED06970900852235 EUDAMED06970900852204 EUDAMED06970900852228 EUDAMED06970900852211 EUDAMED06970900852181 EUDAMED
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06970900852501 EUDAMED06970900852310 EUDAMED06970900859104 EUDAMED06970900859050 EUDAMED06936603203972 EUDAMED06970900852303 EUDAMED06970900852549 EUDAMED06970900852464 EUDAMED06970900852280 EUDAMED06970900852235 EUDAMED06970900852204 EUDAMED06970900852228 EUDAMED06970900852211 EUDAMED06970900852181 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDGermany 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
neopiston® 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.
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- 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 |
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Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (15)
- EUDAMED 4b440335-69e7-4ada-94ab-246f32499579 61 fields · synced Oct 6, 2026
- EUDAMED 2e4b74fd-961c-41fe-a586-a29f36f2c8fe 61 fields · synced May 16, 2026
- EUDAMED 948e54d1-f320-47a4-a536-d5ed3057a0fb 61 fields · synced May 16, 2026
- EUDAMED 574180ff-5933-4503-87c2-cfec20238595 61 fields · synced May 16, 2026
- EUDAMED a834a467-a285-494b-98e1-f9207c3b0fe0 61 fields · synced May 17, 2026
- EUDAMED 79b6949b-36a4-4391-a0d1-04716727accc 61 fields · synced May 17, 2026
- EUDAMED 030c6370-bdc4-44f5-84ea-b1329684641a 61 fields · synced May 17, 2026
- EUDAMED bd89d77b-7a15-40c1-b513-c71031b25e61 61 fields · synced May 18, 2026
- EUDAMED ad8e2b06-83ef-4751-a438-056fd8a6f6b7 61 fields · synced May 18, 2026
- EUDAMED a29eb525-08b6-4a40-bde3-a5b24806eac4 61 fields · synced May 18, 2026
- EUDAMED 8e82499a-18c1-40e5-8304-6f18efb8e989 61 fields · synced May 18, 2026
- EUDAMED a6d0e8ef-ca7f-4e02-ad49-a7ac86725800 61 fields · synced May 18, 2026
- EUDAMED 085090c2-932e-4896-8c51-d43f5e7b20e6 61 fields · synced May 19, 2026
- EUDAMED e5729cd0-b245-48bd-ac18-886a98451488 61 fields · synced May 19, 2026
- EUDAMED 9744852c-3339-4f39-8232-60f6d265a4d6 61 fields · synced Jul 12, 2026