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Disposable Core Biopsy Instruments
EUDAMEDClass IIa (EU MDR)
Ref 100012188Model BN-OCR-1/1410，BN-OCR-1/1416，BN-OCR-1/1610，BN-OCR-1/1616，BN-OCR-1/1810，BN-OCR-1/1816，BN-OCR-1/1820，BN-OCR-1/1825，BN-OCR-1/2010，BN-OCR-1/2016，BN-OCR-1/2020Ref 100022116Model BN-OCR-1/1410A，BN-OCR-1/1410B，BN-OCR-1/1410C，BN-OCR-1/1416A，BN-OCR-1/1416B，BN-OCR-1/1416C，BN-OCR-1/1610A，BN-OCR-1/1610B，BN-OCR-1/1610C，BN-OCR-1/1616A，BN-OCR-1/1616B，etcRef 100022108Ref 100022096Ref 100022109Ref 100022119Ref 100022092Ref 100022121Ref 100022122Ref 100022114Ref 100012181Ref 100022103Ref 100012183Ref 100022110Ref 100022098Ref 100022113Ref 100022106Ref 100022107Ref 100022115Ref 100022102
Identity
- Trade Name
- Disposable Core Biopsy Instruments EUDAMED
- Device Name
- Disposable Core Biopsy Instruments EUDAMED
- Model / Reference
- BN-OCR-1/1410，BN-OCR-1/1416，BN-OCR-1/1610，BN-OCR-1/1616，BN-OCR-1/1810，BN-OCR-1/1816，BN-OCR-1/1820，BN-OCR-1/1825，BN-OCR-1/2010，BN-OCR-1/2016，BN-OCR-1/2020 EUDAMED100012188 EUDAMEDBN-OCR-1/1410A，BN-OCR-1/1410B，BN-OCR-1/1410C，BN-OCR-1/1416A，BN-OCR-1/1416B，BN-OCR-1/1416C，BN-OCR-1/1610A，BN-OCR-1/1610B，BN-OCR-1/1610C，BN-OCR-1/1616A，BN-OCR-1/1616B，etc EUDAMED100022116 EUDAMED100022108 EUDAMED100022096 EUDAMED100022109 EUDAMED100022119 EUDAMED100022092 EUDAMED100022121 EUDAMED100022122 EUDAMED100022114 EUDAMED100012181 EUDAMED100022103 EUDAMED100012183 EUDAMED100022110 EUDAMED100022098 EUDAMED100022113 EUDAMED100022106 EUDAMED100022107 EUDAMED100022115 EUDAMED100022102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971944912930 EUDAMED06942067975911 EUDAMED06942067975805 EUDAMED06942067975713 EUDAMED06942067975812 EUDAMED06942067975942 EUDAMED06942067975676 EUDAMED06942067975966 EUDAMED06942067975973 EUDAMED06942067975867 EUDAMED06971944912862 EUDAMED06942067977991 EUDAMED06971944912886 EUDAMED06942067975829 EUDAMED06942067975737 EUDAMED06942067975850 EUDAMED06942067975782 EUDAMED06942067975799 EUDAMED06942067975904 EUDAMED06942067975775 EUDAMED
- Basic UDI-DI
- 697194491BN-OCRLM EUDAMED69420679BN-OCR-1SN EUDAMED
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Disposable Core Biopsy Instruments by Ningbo Xinwell Medical Technology 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 | 697194491BN-OCRLM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Xinwell Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000001084
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (20)
- EUDAMED af302052-5d76-4f71-95b1-9e351c3687de 61 fields · synced Aug 4, 2026
- EUDAMED 5cdceecc-eaa2-4996-8f69-d07607f6552b 61 fields · synced May 16, 2026
- EUDAMED dc59124b-2ac7-4f4c-acb3-3ec776f81288 61 fields · synced May 16, 2026
- EUDAMED fddfff1b-620e-49f2-ad50-9839ab9dccb5 61 fields · synced May 16, 2026
- EUDAMED 6e44c707-ed87-45fa-8f5a-92b623d7d7e5 61 fields · synced May 17, 2026
- EUDAMED ea139d3d-0fba-4a15-ae3f-0d1800286b73 61 fields · synced May 18, 2026
- EUDAMED 826580c3-2238-42e5-867a-ae507d3743e9 61 fields · synced May 18, 2026
- EUDAMED 660b8710-21fa-4cec-bcda-778125c1795e 61 fields · synced May 18, 2026
- EUDAMED 55262caa-df82-4790-b0f9-2de0de558cc3 61 fields · synced May 18, 2026
- EUDAMED 2f148923-7297-4c0d-b46d-0acacaf3f429 61 fields · synced May 18, 2026
- EUDAMED 339d536e-82e6-49fa-bafd-18c9f49f9713 61 fields · synced May 18, 2026
- EUDAMED d85ae9f2-4a71-4b61-8445-cd8060fe15bc 61 fields · synced May 18, 2026
- EUDAMED 724c1423-f476-4bfb-bf82-1e96d5416075 61 fields · synced May 18, 2026
- EUDAMED 93b12614-0d94-44a3-af4d-28090bd59e08 61 fields · synced May 18, 2026
- EUDAMED 35972c40-2796-41bb-8ec5-a5244334ab7f 61 fields · synced May 18, 2026
- EUDAMED 8479fc29-9413-44c5-9a53-8c34ecea4ed0 61 fields · synced May 18, 2026
- EUDAMED 44de3624-4064-4adf-a893-0560f332190a 61 fields · synced May 18, 2026
- EUDAMED bd17d912-4156-4d0b-a04c-070f5bed9c20 61 fields · synced May 18, 2026
- EUDAMED 4822fc59-3178-4dd7-9581-c72b7f5e9f80 61 fields · synced May 19, 2026
- EUDAMED 932fe101-60cc-43f3-9362-e85905f86ff1 61 fields · synced May 19, 2026