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Techno Cut

by HMD Healthcare India Pvt. Ltd. 36 variants

Ref 1738

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

CE MDR

Valid until

11 Jun 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

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
European UnionCE/MDR EUDAMED Number1000315516 Date20 Aug 2026IssuedStatusActive expires 11 Jun 2030
United StatesGUDID listing GUDID Number18904233117384 UDI-DI Date1 Jul 2020ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000315516 Active Amended

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    20 Aug 2026
    Expires
    11 Jun 2030
    Reason
    Mnf data change

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  • Withdrawn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
Scalpel, single-use
Model / Ref / Catalog
1738 EUDAMED
#12 GUDID
01738 GUDID
Primary DI / UDI-DI
18904233117384
Basic UDI-DI
89042331V01WV
Direct Marketing DI
18904233117384
FDA Product Code
GES
EMDN Code
V010102, V0199
GMDN Term
Scalpel, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1738
GUDID
#12
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IN-MF-000020562
Authorised representative
Advena Limited MT-AR-000000234

Other devices from HMD Healthcare India Pvt. Ltd.

  • Techno Cut

    Class IIa
  • Techno Cut

    Class IIa
  • Techno Cut

    Class IIa
  • Techno Cut

    Class IIa
  • Techno Cut

    Class IIa
  • Techno Cut

    Class IIa

See all devices from HMD Healthcare India Pvt. Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Serial Number: No
  • Manufacturing Date: No