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VoiceInject® injection needles

by SPIGGLE & THEIS Medizintechnik GmbH

Ref 3080-1000-11

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

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number425038187H0201SQ Basic UDI-DI 04250676744210UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250676744210 UDI-DI Date23 Oct 2025ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
VoiceInject® injection needles EUDAMED
VoiceInject injection needle GUDID
Generic Name
Tissue injection cannula
Device Name
injection needles
Model / Ref / Catalog
3080-1000-11
Description
Artificial filler ID 1.2mm, sterile
Primary DI / UDI-DI
04250676744210
Basic UDI-DI
425038187H0201SQ
FDA Product Code
GAA
EMDN Code
K01020110 Minimally invasive surgery cannulas, single-use
GMDN Term
Tissue injection cannula
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
DE-MF-000006647

Other devices from SPIGGLE & THEIS Medizintechnik GmbH

See all devices from SPIGGLE & THEIS Medizintechnik GmbH →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No