Skip to content

Altech®

by Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.Ş. 2 variants

Ref 104001, 104003

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++M712104SPECULUM2A Basic UDI-DI Date21 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
ALTECH® Vaginal Speculum
Model / Reference
104001, 104003
Primary DI / UDI-DI
+M7121040011., +M7121040031$
Basic UDI-DI
++M712104SPECULUM2A
Direct Marketing DI
+M7121040011.
+M7121040031$
EMDN Code
U089006 Vaginal speculum, single-use
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000025066

Other devices from Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.Ş.

See all devices from Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.Ş. →

Properties

Other properties (13)

  • Sterile: 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