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Non-Sterile Single Use Hartmann Ear Specula Baby Aural. Inside Non-Reflective/Outside Mirror Finish -OD 3.0mm

by Beauty Teck International (Pvt) Ltd

Ref BTOF1033, BTOF1177, BTOF1155, BTOF1022

Active European Union

CE MDD

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/MDD NumberB-+G075BTOF10330Q Basic UDI-DI Date5 May 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Trade Name
Non-Sterile Single Use Hartmann Ear Specula Baby Aural. Inside Non-Reflective/Outside Mirror Finish -OD 3.0mm
Non-Sterile Single Use Hartmann Ear Specula Baby Aural. Inside Non-Reflective/Outside Mirror Finish -OD 4.6mm
Non-Sterile Single Use Hartmann Ear Specula Baby Aural. Inside Non-Reflective/Outside Mirror Finish -OD 1.0mm
Non-Sterile Single Use Hartmann Ear Specula Baby Aural. Inside Non-Reflective/Outside Mirror Finish -OD 2.0mm
Model / Reference
BTOF1033, BTOF1177, BTOF1155, BTOF1022
Primary DI / UDI-DI
+G075BTOF10330Q, +G075BTOF11770Z, +G075BTOF11550V, +G075BTOF10220O
Basic UDI-DI
B-+G075BTOF10330Q, B-+G075BTOF11770Z, B-+G075BTOF11550V, B-+G075BTOF10220O
EMDN Code
Q030312 ENT surgery spatulas, single-use
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
PK-MF-000009604
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No