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Labomed

by Labotech Microscopes India Pvt. Ltd. India EUDAMEDGUDID

Ref 6137202 / 6138000-796Model 6138000 Product code FSOEMDN Z12011101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8908006463613-PR-DNTNJ Basic UDI-DIDate25 Mar 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08908006463084 UDI-DIDate13 Dec 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Labomed EUDAMED
Labomed Prima DNT Microscope Ceiling Mount Long Arm GUDID
Generic Name
Dental surgical microscope
Device Name
Prima DNT - Dental Microscope Mobile mount
Model / Reference
6138000 EUDAMED
6137202 / 6138000-796 EUDAMED
6137202 GUDID
Primary DI / UDI-DI
08908006463084
Basic UDI-DI
8908006463613-PR-DNTNJ
Direct Marketing DI
08908006463084
FDA Product Code
FSO
EMDN Code
Z12011101 Operative microscopes
GMDN Term
Dental surgical microscope
Device Class
Class I
Regulation Number
878.4700
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
6138000
6137202 / 6138000-796
GUDID
6137202

Manufacturer details

EUDAMED SRN
IN-MF-000033373
Authorised representative
Labomed Europe b.v. NL-AR-000022889

Other devices from Labotech Microscopes India Pvt. Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • 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
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED fe3a45f3-e858-4d73-b0dc-5f47d029666b 61 fields · synced 22 Oct 2026
  • FDA UDI adc95904-ca61-4e49-a694-f1fc3bd7bc29 34 fields · synced 30 May 2026