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Vital SignsTM ECG Paper, MAC® Series, 8 years Imaged Archival Life, 110mm, Red Grid, Z-Fold

by AirLife Finland Oy

Ref 2036970-001

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0889483TF20041hPaperHH Basic UDI-DI 10889483576557UDI-DIDate8 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889483576557 UDI-DI Date17 Apr 2025ListedStatusListed 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  • Withdrawn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
Vital SignsTM ECG Paper, MAC® Series, 8 years Imaged Archival Life, 110mm, Red Grid, Z-Fold EUDAMED
Vital Signs™ GUDID
Generic Name
Electrocardiographic recording paper
Model / Ref / Catalog
2036970-001
Primary DI / UDI-DI
10889483576557
Basic UDI-DI
0889483TF20041hPaperHH
FDA Product Code
DSF
EMDN Code
Z1302 Diagnostic registration papers
GMDN Term
Electrocardiographic recording paper
Device Class
Class I
Regulation Number
870.2810
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
FI-MF-000001482

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Properties

  • Single Use
  • Measuring Function
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: 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
  • Serial Number: No