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tamburo

by menovex Medical Technology (Shenzhen) Co., Ltd 3 variants

Ref MIL-TFL-600CModel MIL-TFL-600A, MIL-TFL-600B, MIL-TFL-600C

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697499431RA2402LH Basic UDI-DI 06974994310558UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06974994310558 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 23 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  • Withdrawn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 Fiber Laser System GUDID
Generic Name
General/multiple surgical solid-state laser system
Model / Reference
MIL-TFL-600A, MIL-TFL-600B, MIL-TFL-600C
Primary DI / UDI-DI
06974994310558 EUDAMED
06974994310404 GUDID
Basic UDI-DI
697499431RA2402LH
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011099 Laser surgery instruments - other
GMDN Term
General/multiple surgical solid-state laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06974994310558
GUDID
06974994310404
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000046013
Authorised representative
Eunitor GmbH DE-AR-000005081

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

See all devices from menovex Medical Technology (Shenzhen) Co., Ltd →

Properties

  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • 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
  • Lot / Batch Number: No