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Anesthesia System

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 3 variants

Ref A5

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

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171311↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06944904030272 Basic UDI-DI 06944904030272UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK171311 Date12 Jan 2018IssuedStatusActive
United StatesGUDID listing GUDID Number06944904030272 UDI-DI Date20 Oct 2015ListedStatusListed 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.

Recalls

1 recall · FDA

    • Terminated Z-0846-2018 FDA Class II initiated 14 Jul 2017

    A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Anesthesia System EUDAMED
A5 Anesthesia System GUDID
Generic Name
Anaesthesia unit, mobile
Model / Reference
A5
Primary DI / UDI-DI
06944904030272
Basic UDI-DI
B-06944904030272
510(k) Number
FDA Product Code
BSZ
EMDN Code
Z1203010101 Anaesthesia devices
GMDN Term
Anaesthesia unit, mobile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5160
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties

  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No