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Disposable Biopsy Needle

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 1050001018Model CMBNA/1810, CMBNA/1815, CMBNA/1820Ref 1050001016Ref 1050001017

by Carbon (Shenzhen) Medical Device Co., Ltd.

Identity

Device Name
Disposable Biopsy Needle EUDAMED
Model / Reference
CMBNA/1810, CMBNA/1815, CMBNA/1820 EUDAMED
1050001018 EUDAMED
1050001016 EUDAMED
1050001017 EUDAMED

Identifiers

Primary DI / UDI-DI
16974405094913 EUDAMED
16974405095026 EUDAMED
16974405095019 EUDAMED
Basic UDI-DI
697440509CMBNAH6 EUDAMED
EMDN Code
A0102010101 SHEARING BIOPSY NEEDLES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Netherlands 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 Biopsy Needle by Carbon (Shenzhen) Medical Device Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Carbon (Shenzhen) Medical Device Co., Ltd.
EUDAMED SRN
CN-MF-000031536
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED 87636b5f-6cbf-45d2-a73a-6f0094038845 61 fields · synced Jul 10, 2026
  • EUDAMED 7e3ba5c3-36ff-40ce-9d22-bde5b208541e 61 fields · synced May 17, 2026
  • EUDAMED 982450ed-57e1-4d37-a4ec-637f564fe495 61 fields · synced May 18, 2026
  • FDA 510(k) K243296 1 fields · synced May 18, 2026