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Autoclave

by Changsha Yingtai Instrument Co., Ltd 8 variants

Part of a family of 8 devices: see the family page

Ref 073

Autoclave (073) is a steam sterilizer (EU MDR Class I; FDA Class I; FDA product code LRJ, Disinfectant, Medical Devices) made by Changsha Yingtai Instrument Co., Ltd, registered in EUDAMED on 18 Jul 2025 (Basic UDI-DI 697630191AutoclaveZV) and listed in FDA GUDID since 1 Mar 2025 (UDI-DI 06976301910734), 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 Number697630191AutoclaveZV Basic UDI-DI 06976301910734UDI-DIDate18 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06976301910734 UDI-DI Date1 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697630191AutoclaveZV registered 18 Jul 2025 Active
  • FDA GUDID UDI-DI 06976301910734 listed 1 Mar 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06976301910734
  2. Registered EUDAMED 697630191AutoclaveZV

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  • Withdrawn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
Yingtai
Generic name
Steam sterilizer
Model / reference
073 EUDAMED
HB-65C GUDID
Primary DI / UDI-DI
06976301910734
Basic UDI-DI
697630191AutoclaveZV
Direct marketing DI
06976301910734
FDA product code
LRJ
EMDN code
S9099 Sterilisation devices (excluding cat. d - z) - other
GMDN term
Steam sterilizer
Device class
Class I
Regulation number
880.6890
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
073
GUDID
HB-65C

Manufacturer details

EUDAMED SRN
CN-MF-000034851
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Similar devices in this category

Other devices filed under STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER.

Other devices from Changsha Yingtai Instrument Co., Ltd

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Properties

  • Premarket exempt
  • Manufacturing date
Other properties (23, all answered No)