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Non-vascular Guidewire
EUDAMEDClass IIa (EU MDR)
Ref JHY-GW-88-215-A1Ref JHY-GW-88-350-A1
Identity
- Trade Name
- Non-vascular Guidewire EUDAMEDNon-vascular Guidewires EUDAMED
- Device Name
- Non-vascular Guidewire EUDAMEDNon-vascular Guidewires EUDAMED
- Model / Reference
- JHY-GW-88-215-A1 EUDAMEDJHY-GW-88-350-A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942000240786 EUDAMED06942000240939 EUDAMED
- Basic UDI-DI
- B-06942000240786 EUDAMEDB-06942000240939 EUDAMED69420002047NH 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
- Germany EUDAMEDFrance 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
Non-vascular Guidewire by Changzhou Jiuhong Medical Instrument Co., Ltd. — Class IIa — MDR, MDD — 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
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- 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06942000240786 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06942000240786 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Jiuhong Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000016791
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (3)
- EUDAMED 0bb141d3-8d6b-47f2-ad40-385dd9a44fad 61 fields · synced Jul 14, 2026
- EUDAMED fe68c4a1-0944-4091-b37d-bea773fdb3fd 61 fields · synced May 17, 2026
- EUDAMED 12e8cb35-2b91-4a37-a6cf-a05b98cff86b 61 fields · synced Jun 19, 2026