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Norav 1200 Series PC-ECG SW M1

by Norav Medical Inc.

Ref HASP-SW-K-M1-01Model PC-ECG 1200 Software-Options

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

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
European UnionCE/MDR EUDAMED Number0729011720NM2069202KEYCW Basic UDI-DI 07290110252663UDI-DIDate5 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290110252663 UDI-DI Date1 Oct 2019ListedStatusListed 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.

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  • Withdrawn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
PC-ECG Option M1 EUDAMED
Norav 1200 Series PC-ECG GUDID
Generic Name
Patient monitoring system module, electrocardiographic, long-term recording
Device Name
PC-ECG 1200 Series
Model / Ref / Catalog
PC-ECG 1200 Software-Options, HASP-SW-K-M1-01, SW M1
Primary DI / UDI-DI
07290110252663
Basic UDI-DI
0729011720NM2069202KEYCW
FDA Product Code
MWI
EMDN Code
Z12050192 Stress analysis instruments - medical device software
GMDN Term
Patient monitoring system module, electrocardiographic, long-term recording
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2300
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PC-ECG 1200 Software-Options
HASP-SW-K-M1-01
GUDID
SW M1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Patient monitoring system module, electrocardiographic, long-term recording

Other devices from Norav Medical Inc.

See all devices from Norav Medical Inc. →

Properties

  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No