Identity
- Device Name
- Disposable Trocar EUDAMED
- Model / Reference
- BLBSP3 EUDAMEDBLHNS10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949298956429 EUDAMED
- Basic UDI-DI
- 69492989LS0007WH EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
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
Disposable Trocar by Jiangsu Brightness Medical Devices 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 | 69492989LS0007WH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Brightness Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000019184
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (2)
- EUDAMED 632af889-806b-4462-a747-2ea133857ac3 61 fields · synced Jun 19, 2026
- EUDAMED 2f29b020-612d-415d-adce-0dbf6aa369a1 61 fields · synced Jun 19, 2026