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Disposable Dual bore BSS injection needle. (41 gauge / 0.1 mm) 1270.06

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Ref 1270.06

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

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08717872025759 Basic UDI-DI 08717872025759UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717872025759 UDI-DI Date11 Feb 2021ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Disposable Dual bore BSS injection needle (41 gauge / 0.1 mm) EUDAMED
Disposable Dual bore BSS injection needle. (41 gauge / 0.1 mm) GUDID
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Model / Ref / Catalog
1270.06
Primary DI / UDI-DI
08717872025759
Basic UDI-DI
B-08717872025759
FDA Product Code
HMX
EMDN Code
A010599 Ophthalmology injection needles and kits - other
GMDN Term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4350
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Other devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

See all devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. →

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