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tamburo Thulium Laser Fiber SF-365-BPA

by menovex Medical Technology (Shenzhen) Co., Ltd

Ref SF-365-BPAModel SF-150-APA,SF-150-BPA,SF-200-APA,SF-200-BPA,SF-272-APA,SF-272-BPA,SF-365-APA,SF-365-BPA,SF-550-APA,SF-550-BPA,SF-800-APA,SF-800-BPA

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697499431RA2403LK Basic UDI-DI 06974994310633UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06974994310633 UDI-DI Date11 Dec 2025ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
tamburo EUDAMED
tamburo Thulium Laser Fiber GUDID
Generic Name
General/multiple surgical laser system beam guide, single-use
Model / Reference
SF-365-BPA, SF-150-APA, SF-150-BPA, SF-200-APA, SF-200-BPA, SF-272-APA, SF-272-BPA, SF-365-APA, SF-550-APA, SF-550-BPA, SF-800-APA, SF-800-BPA
Primary DI / UDI-DI
06974994310633 EUDAMED
06974994310480 GUDID
Basic UDI-DI
697499431RA2403LK
Unit of Use DI
86974994310639
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011085 Laser surgery instruments - consumables
GMDN Term
General/multiple surgical laser system beam guide, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06974994310633
GUDID
06974994310480
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K251303)

Other devices from menovex Medical Technology (Shenzhen) Co., Ltd

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Properties

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

Other properties (18)

  • 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