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Disposable Non-vascular Guidewires
EUDAMEDClass IIa (EU MDR)
Ref ENDO-GW-88-350-B1Model ENDO-GWRef ENDO-GW-88-450-B1Ref ENDO-GW-88-300-B1Ref ENDO-GW-88-215-B1Ref ENDO-GW-88-450-A1Ref ENDO-GW-88-350-A1Ref ENDO-GW-88-215-A1Ref ENDO-GW-88-260-B1
Identity
- Device Name
- Disposable Non-vascular Guidewires EUDAMED
- Model / Reference
- ENDO-GW EUDAMEDENDO-GW-88-350-B1 EUDAMEDENDO-GW-88-450-B1 EUDAMEDENDO-GW-88-300-B1 EUDAMEDENDO-GW-88-215-B1 EUDAMEDENDO-GW-88-450-A1 EUDAMEDENDO-GW-88-350-A1 EUDAMEDENDO-GW-88-215-A1 EUDAMEDENDO-GW-88-260-B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975597851707 EUDAMED06975597851714 EUDAMED06975597851691 EUDAMED06975597851677 EUDAMED06975597851660 EUDAMED06975597851653 EUDAMED06975597851622 EUDAMED06975597851684 EUDAMED
- Basic UDI-DI
- 697559785PE08UJ EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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: Tissue morcellation system handpiece, line-powered
Disposable Non-vascular Guidewires by Jiangsu Power-endo Medical Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system handpiece, line-powered.
- Aveta Disposable Resecting Device 2.9 mm — Meditrina, Inc. · Class II
- Disposable Guidewire — Alton (Shanghai) Medical Instruments Co., Ltd. · Class I
- Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class I
- Polyp Traps — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- 2-piece Cleaning Adapter + 4-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class IIa
- Guide Wires — Changzhou Health Microport Medical Device Co., Ltd · Class IIa
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc. · Class II
- 3-piece valve kit — GA HEALTH COMPANY 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 | 697559785PE08UJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Power-endo Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000030213
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (8)
- EUDAMED 14ca6f64-21ae-4b17-9ea2-eb5c5574c3f8 61 fields · synced Oct 6, 2026
- EUDAMED b52dc2cd-6e2e-43e6-8340-5a12ceb5a9f8 61 fields · synced May 16, 2026
- EUDAMED d5381553-5aae-48ac-8804-31c69e7614de 61 fields · synced May 17, 2026
- EUDAMED a7e88478-bd1e-482a-95da-05e5c925b1b2 61 fields · synced May 17, 2026
- EUDAMED 25349469-8aaa-4e9f-b377-448ba829eee4 61 fields · synced May 17, 2026
- EUDAMED 103ba36e-4e49-45e0-a7a3-da70152ca212 61 fields · synced May 18, 2026
- EUDAMED 1204c7b8-5998-4782-abfa-9998704562b4 61 fields · synced May 18, 2026
- EUDAMED 95970f9e-7ea1-46ef-9335-5fb0fd3bcaa6 61 fields · synced May 18, 2026