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by MacroLux Medical Technology Co., Ltd. 6 variants

Ref C38-CRSModel C38-CS/ C38-CRS/ C50-C/ C50-CR/ C50-CB/ C50-CBR

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975339621513 UDI-DI Date14 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697533962004MQ Basic UDI-DI 06975339621513UDI-DIDate29 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Generic Name
Flexible video cystoscope, single-use
Model / Reference
C38-CS/ C38-CRS/ C50-C/ C50-CR/ C50-CB/ C50-CBR, C38-CRS
Description
C38-CRS Single-Use Digital Flexible Cystoscope
Primary DI / UDI-DI
06975339621513
Basic UDI-DI
697533962004MQ
FDA Product Code
FGB, FAJ
EMDN Code
Z12020701 Cystoscopes
GMDN Term
Flexible video cystoscope, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
Market of Registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000025085
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from MacroLux Medical Technology Co., Ltd.

See all devices from MacroLux Medical Technology Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No