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Disposable Needle-guided Bracket

by Carbon (Shenzhen) Medical Device Co., Ltd. 2 variants

Ref 1070002002Model VE-C01, VE-L01

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

19 Jan 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974405095180 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberCN26/00000436 Date20 Apr 2026IssuedStatusActive expires 19 Jan 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00000436 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    20 Apr 2026
    Expires
    19 Jan 2031
    Reason
    Add device or group

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
CarbonMed
Generic Name
Needle guide, single-use
Device Name
Disposable Needle-guided Bracket
Model / Reference
VE-C01, VE-L01, 1070002002
Primary DI / UDI-DI
06974405095180
Basic UDI-DI
697440509VECL01LQ
Direct Marketing DI
06974405095180
FDA Product Code
IQG
EMDN Code
A018002 Needle guides
GMDN Term
Needle guide, single-use
Device Class
Class I
Regulation Number
890.5050
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
VE-C01, VE-L01
1070002002
GUDID
VE-L01

Manufacturer details

EUDAMED SRN
CN-MF-000031536
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Carbon (Shenzhen) Medical Device Co., Ltd.

See all devices from Carbon (Shenzhen) Medical Device Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No