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Anesthesia System

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

Ref A8

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

6 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06936415912277 Basic UDI-DI 06936415912277UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936415912277 UDI-DI Date15 Jul 2021ListedStatusListed 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

6 recalls · 6 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0720-2026 FDA Class II initiated 20 Oct 2025
    • Ongoing Z-0721-2026 FDA Class II initiated 20 Oct 2025

    Potential for anesthesia leakage.

  • 4 recalls, same reason

    • Ongoing Z-2949-2024 FDA Class II initiated 22 Jul 2024
    • Ongoing Z-2951-2024 FDA Class II initiated 22 Jul 2024
    • Ongoing Z-2952-2024 FDA Class II initiated 22 Jul 2024
    • Ongoing Z-2950-2024 FDA Class II initiated 22 Jul 2024

    V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention

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  • Withdrawn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

Generic Name
Anaesthesia unit, mobile
Model / Reference
A8
Primary DI / UDI-DI
06936415912277
Basic UDI-DI
B-06936415912277
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 · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
Contains LatexEUDAMED
No
GUDID
Yes

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

  • Contains Latex NoEUDAMEDYesGUDID
  • Administering Medicine
  • Measuring Function
  • Serial Number
  • Manufacturing Date

Other properties (17)

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