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House Micro Ear Curette 14.5 cm - 5 3/4" Cup Size 1 / Cup Size 2 1.0 mm - 1.2 mm Stainless Steel

by Surtex Instruments Ltd 2 variants

Ref OT-520-03, OT-520-04, OT-521-02, OT-521-03, OT-521-01Model 50554459CURETTEIR149001JG

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

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05055445969721 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number50554459CUTTINGINSTRL2 Basic UDI-DI Date13 Mar 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number50554459CUTTINGINSTRL2 Basic UDI-DI Date13 Mar 2026RegisteredStatusActive

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
House Micro Ear Curette 14.5 cm - 5 3/4" Cup Size 1 / Cup Size 2 1.0 mm - 1.2 mm Stainless Steel EUDAMED
House Micro Ear Curette 14.5 cm - 5 3/4" Cup Size 1 / Cup Size 2 1.5 mm - 1.8 mm Stainless Steel EUDAMED
House Micro Ear Curette 14.5 cm - 5 3/4" Cup Size 2.2 x 3.8 mm & 2.8 x 4.8 mm Stainless Steel EUDAMED
House Micro Ear Curette 14.5 cm - 5 3/4" Cup Size 0.6 x 0.8 mm & 0.8 x 1.0 mm Stainless Steel EUDAMED
House Micro Ear Curette 14.5 cm - 5 3/4" Cup Size 2.8 x 3.2 mm & 2.6 x 3.5 mm Stainless Steel EUDAMED
Surtex GUDID
Generic Name
General-purpose curette
Device Name
Cutting Instruments
Ent curettes, reusable
Model / Reference
OT-520-03, OT-520-04, OT-521-02, OT-521-03, OT-521-01, 50554459CURETTEIR149001JG
Primary DI / UDI-DI
05055445969721, 05055445969738, 05056111340271, 05056111340288, 05056111340264
Basic UDI-DI
50554459CUTTINGINSTRL2, B-05056111340288, B-05055445969738, B-05055445969721, B-05056111340271, B-05056111340264
FDA Product Code
FZS
EMDN Code
L149001 ENT curettes, reusable
GMDN Term
General-purpose curette
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Manufacturer details

EUDAMED SRN
GB-MF-000023183
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Surtex Instruments Ltd

See all devices from Surtex Instruments Ltd →

Properties

  • Reusable
  • Premarket Exempt

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No