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SeeStar 12G

by AprioMed AB

Ref 13312

SeeStar 12G (13312) is a Class I device made by Apriomed AB, registered in EUDAMED on 20 May 2025 (Basic UDI-DI 73500313514KN) and listed in FDA GUDID since 24 Apr 2023 (UDI-DI 07350031350494), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73500313514KN Basic UDI-DI 07350031350494UDI-DIDate20 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07350031350494 UDI-DI Date24 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 73500313514KN registered 20 May 2025 Active
  • FDA GUDID UDI-DI 07350031350494 listed 24 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07350031350494
  2. Registered EUDAMED 73500313514KN

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  • Withdrawn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
SeeStar 12G EUDAMED
SeeStar GUDID
Generic name
Needle guide, single-use
Model / Ref / Catalog
13312, G049
Primary DI / UDI-DI
07350031350494
Basic UDI-DI
73500313514KN
FDA product code
GDF
EMDN code
A018002 Needle guides
GMDN term
Needle guide, single-use
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Needle Gauge — 12 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
13312
GUDID
G049

Manufacturer details

EUDAMED SRN
SE-MF-000001013

Similar devices in this category

Other devices filed under NEEDLE GUIDES.

Other devices from Apriomed AB

See all devices from Apriomed AB →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)