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Pulse Oximeter

by Shenzhen Narig Bio-Medical Technology Co., Ltd.

Ref FRO-203Model FRO-200,FRO-201,FRO-202,FRO-203, FRO-204, FRO-100, FRO-101, FRO-102,FRO-103, FRO-104

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211632↗

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/MDR EUDAMED Number697392716FROVN Basic UDI-DI Date17 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06973927160185 UDI-DI Date31 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK211632 Date14 Jan 2022IssuedStatusActive

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 24 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  • Withdrawn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

Generic Name
Pulse oximeter
Model / Reference
FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104
Primary DI / UDI-DI
06973927160185, 06973927160086
Basic UDI-DI
697392716FROVN
Direct Marketing DI
06973927160185
06973927160086
510(k) Number
FDA Product Code
DQA
EMDN Code
Z1203020408 Pulse oximeters
GMDN Term
Pulse oximeter
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2700
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 IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000007087
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Shenzhen Narig Bio-Medical Technology Co., Ltd.

See all devices from Shenzhen Narig Bio-Medical Technology Co., Ltd. →

Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No