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Disposable Core Biopsy Instruments

EUDAMED

Class IIa (EU MDR)

Ref 100022112Model 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，etc

by Ningbo Xinwell Medical Technology Co., Ltd

Identity

Trade Name
Disposable Core Biopsy Instruments EUDAMED
Device Name
Disposable Core Biopsy Instruments EUDAMED
Model / Reference
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，etc EUDAMED
100022112 EUDAMED

Identifiers

Primary DI / UDI-DI
06942067975843 EUDAMED
Basic UDI-DI
69420679BN-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

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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 (1)

  • EUDAMED 8fb564a7-9807-44b7-a52f-e471a24f2eeb 61 fields · synced Jun 18, 2026