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Guide Wire With Hydrophilic Coating
EUDAMEDClass IIa (EU MDR)
Ref 32618012Model Hydrophilic Guidewire：0.018”，0.025”，0.028”，0.032”，0.035”，0.038”
Identity
- Trade Name
- Guide Wire With Hydrophilic Coating EUDAMED
- Device Name
- Guidewires EUDAMED
- Model / Reference
- Hydrophilic Guidewire：0.018”，0.025”，0.028”，0.032”，0.035”，0.038” EUDAMED32618012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382610863 EUDAMED
- Basic UDI-DI
- 697209192GDWH19KC EUDAMED
- Direct Marketing DI
- 06942382610863 EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Guide Wire With Hydrophilic Coating by Bonree Medical Co., Ltd. — Class IIa — 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 | 697209192GDWH19KC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bonree Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017844
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 36256054-7f39-486b-84d3-e287b3067cc8 61 fields · synced Oct 7, 2026