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Pc-Ecg 1200hrt

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 1200HRT-D-00U-04Model PC-ECG 1200 Series

by Norav Medical GmbH

Identity

Trade Name
PC-ECG 1200HRT EUDAMED
Norav 1200 Series PC-ECG FDA UDI
Generic Name
Electrocardiographic signal amplifier FDA UDI
Device Name
PC-ECG 1200 EUDAMED
PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG Trigger Output and AHA type labelling. FDA UDI
Model / Reference
PC-ECG 1200 Series EUDAMED
1200HRT-D-00U-04 EUDAMED
1200HRT FDA UDI
Description
PC-ECG Acquisition Device for High Resolution Resting-ECG and Stress-Test ECG recordings with ECG Trigger Output and AHA type labelling. FDA UDI

Identifiers

Catalog Number
1200HRT-D-00U-04 FDA UDI
Primary DI / UDI-DI
04260498566846 EUDAMEDFDA UDI
Basic UDI-DI
426049856DE55252NMDECT9 EUDAMED
Direct Marketing DI
04260498566846 EUDAMED
FDA Product Code
MWI FDA UDI
EMDN Code
Z12050101 STRESS ANALYSIS SYSTEMS EUDAMED
GMDN Term
Electrocardiographic signal amplifier FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Pc-Ecg 1200hrt by Norav Medical GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Norav Medical GmbH
EUDAMED SRN
DE-MF-000006715

Sources (2)

  • EUDAMED d7d101a2-2672-4db3-8fff-957c4d29ada5 61 fields · synced Oct 6, 2026
  • FDA UDI a822bef6-196c-4ced-b5a1-fcb16af46f67 35 fields · synced May 30, 2026