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Vapofil™ 8907-H

by Southmedic Incorporated

Part of a family of 7 devices: see the family page

Ref 8907-HModel 8907-S

Vapofil™ 8907-H is a device classified as Class I in the EU and Class II in the US made by Southmedic Incorporated, registered in EUDAMED on 6 Aug 2026 (Basic UDI-DI 6209740064131918B4), cleared under FDA 510(k) K843993 on 15 Nov 1984 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 10620974001970), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K843993

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6209740064131918B4 Basic UDI-DI 10620974001970UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10620974001970 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK843993 Date15 Nov 1984DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6209740064131918B4 registered 6 Aug 2026 Active
  • FDA 510(k) K843993 decided 15 Nov 1984 Active
  • FDA GUDID UDI-DI 10620974001970 listed 1 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K843993
  2. Listed FDA GUDID 10620974001970
  3. Registered EUDAMED 6209740064131918B4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Vapofil EUDAMED
Vapofil™ GUDID
Generic name
Halothane anaesthesia vaporizer
Model / Ref / Catalog
8907-H, 8907-S
Primary DI / UDI-DI
10620974001970
Basic UDI-DI
6209740064131918B4
510(k) Number
FDA product code
CAD
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Halothane anaesthesia vaporizer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5880
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Halothane anaesthesia vaporizer

Cleared under the same submission (K843993)

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Southmedic Incorporated

See all devices from Southmedic Incorporated →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)