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BM PTFE Guidewire
EUDAMEDClass IIa (EU MDR)
Ref 327 28 01 2Model PTFE Guidewire：0.018”, 0.025”, 0.028”, 0.032”, 0.035”, 0.038”
Identity
- Trade Name
- BM PTFE Guidewire EUDAMED
- Device Name
- Guidewires EUDAMED
- Model / Reference
- PTFE Guidewire：0.018”, 0.025”, 0.028”, 0.032”, 0.035”, 0.038” EUDAMED327 28 01 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382610825 EUDAMED
- Basic UDI-DI
- 697209192GDWP19LL EUDAMED
- Direct Marketing DI
- 06942382610825 EUDAMED
- EMDN Code
- U0602 UROLOGICAL GUIDEWIRES, NOT 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
BM PTFE Guidewire 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 | 697209192GDWP19LL | 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 5bd0e292-33ed-415a-b8ca-2d17b30f503a 61 fields · synced Oct 6, 2026