Skip to content

Expanding sinus tampon 66310

by Spiggle & Theis Medizintechnik GmbH

Ref 66310

Expanding sinus tampon 66310 is a Class I device made by Spiggle & Theis Medizintechnik GmbH, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-04250381820544) and listed in FDA GUDID since 7 Oct 2025 (UDI-DI 04250381820544), active as of 25 Oct 2026.

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

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250381820544 Basic UDI-DI 04250381820544UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250381820544 UDI-DI Date7 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250381820544 registered 30 Sep 2026 Active
  • FDA GUDID UDI-DI 04250381820544 listed 7 Oct 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250381820544
  2. Registered EUDAMED B-04250381820544

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  • Withdrawn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
Expanding sinus tampon
Generic name
Intranasal splint, non-biodegradable
Device name
PVA-Products
Model / Ref / Catalog
66310
Description
PVA, slimline 35x6x12 mm, sterile, 20 pairs/box
Primary DI / UDI-DI
04250381820544
Basic UDI-DI
B-04250381820544
FDA product code
LYA
EMDN code
M040204 Non-adherent absorbent dressings
GMDN term
Intranasal splint, non-biodegradable
Device class
Class I
Regulation number
874.4780
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 04250381820544: EUDAMED states Yes, FDA GUDID states No.

Similar devices in this category

Other devices filed under NON-ADHERENT ABSORBENT DRESSINGS.

Other devices from Spiggle & Theis Medizintechnik GmbH

See all devices from Spiggle & Theis Medizintechnik GmbH →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)