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Auto Ref/Keratometer

by Ningbo Ming Sing Optical R&D Co., Ltd. 4 variants

Ref RM-9800Model KR-9000

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

CE MDR

Valid until

16 Sep 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971821402097 UDI-DI Date2 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberCN24/00005857 Date16 Sep 2024IssuedStatusActive expires 16 Sep 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN24/00005857 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    16 Sep 2024
    Expires
    16 Sep 2029

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  • Withdrawn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
Auto Ref/Keratometer EUDAMED
36386 GUDID
Generic Name
Automated ophthalmic refractometer
Model / Reference
KR-9000, RM-9800
Primary DI / UDI-DI
06971821402097
Basic UDI-DI
69718214002V8
Direct Marketing DI
06971821402097
FDA Product Code
HKO
EMDN Code
Q0299 Ophthalmic devices - other
GMDN Term
Automated ophthalmic refractometer
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.1760
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000012092
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ningbo Ming Sing Optical R&D Co., Ltd.

See all devices from Ningbo Ming Sing Optical R&D Co., Ltd. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No