Skip to content

Vital Signs Monitor

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

Ref Vital Signs Monitor, VS-600Model VS 9C510(k) K211475

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211475↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06936415973599 UDI-DI Date24 Jan 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69449040AB010000443J Basic UDI-DI Date21 Dec 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK211475 Date5 Oct 2021IssuedStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Vital Signs Monitor EUDAMED
VS 8 Vital Signs Monitor GUDID
VS 8A Vital Signs Monitor GUDID
Generic Name
General-purpose multi-parameter bedside monitor
Model / Reference
VS 9C EUDAMED
Vital Signs Monitor EUDAMED
VS-600 EUDAMED
VS 8 GUDID
VS 8A GUDID
Primary DI / UDI-DI
06936415973599, 06936415973667, 06936415973650, 06936415973612, 06944904040295, 06936415973605, 06936415973636
Basic UDI-DI
69449040AB010000443J, 69449040AB010000453L
510(k) Number
FDA Product Code
MHX 510(k)
MWI GUDID
EMDN Code
Z1203020201, Z12030201
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.1025 510(k)
870.2300 GUDID
EU market of registration
Germany
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

3 sources · 5 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
VS 9C
Vital Signs Monitor
VS-600
510(k)
—
GUDID
VS 8
VS 8A
510(k) NumberEUDAMED
—
510(k)
K060281
GUDID
K211475
K221267
FDA Product CodeEUDAMED
—
510(k)
MHX
GUDID
MWI
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II
Regulation NumberEUDAMED
—
510(k)
870.1025
GUDID
870.2300

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

  • Measuring Function
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: 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