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BM Ureteral Access Sheaths
EUDAMEDClass IIa (EU MDR)
Ref 40211452Model 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr,
Identity
- Trade Name
- BM Ureteral Access Sheaths EUDAMED
- Device Name
- Ureteral Access Sheaths EUDAMED
- Model / Reference
- 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr, EUDAMED40211452 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382610009 EUDAMED
- Basic UDI-DI
- 697209192UAS27LR EUDAMED
- Direct Marketing DI
- 06942382610009 EUDAMED
- EMDN Code
- U0299 URETERAL CATHETERS - OTHER 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 Ureteral Access Sheaths 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 | 697209192UAS27LR | 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 eeafbc7d-e43d-45bd-974e-0e4134280144 61 fields · synced Oct 6, 2026