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Vital SignsTM ECG Paper, MAC® Series, 8 years Imaged Archival Life, 90mm, Z-Fold

by AirLife Finland Oy

Ref 22616702

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 10889483578704UDI-DIDate8 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889483578704 UDI-DI Date22 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  • Withdrawn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, 90mm, Z-Fold EUDAMED
Vital Signs™ GUDID
Generic Name
Electrocardiographic recording paper
Model / Ref / Catalog
22616702
Primary DI / UDI-DI
10889483578704
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