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Vital SignsTM ECG Paper, MAC® Series, 8 years Imaged Archival Life, A4, Red Gri…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 22616605
Identity
- Trade Name
- Vital SignsTM ECG Paper, MAC® Series, 8 years Imaged Archival Life, A4, Red Grid, Z-Fold EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Electrocardiographic recording paper FDA UDI
- Device Name
- Vital Signs ECG Paper EUDAMEDVital Signs™ ECG Paper, MAC® Series, 8 years Imaged Archival Life, A4, Red Grid, Z-Fold FDA UDI
- Model / Reference
- 22616605 EUDAMEDFDA UDI
- Description
- Vital Signs™ ECG Paper, MAC® Series, 8 years Imaged Archival Life, A4, Red Grid, Z-Fold FDA UDI
Identifiers
- Catalog Number
- 22616605 FDA UDI
- Primary DI / UDI-DI
- 10889483578674 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889483TF20041hPaperHH EUDAMED
- FDA Product Code
- DSF FDA UDI
- EMDN Code
- Z1302 DIAGNOSTIC REGISTRATION PAPERS EUDAMED
- GMDN Term
- Electrocardiographic recording paper FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.2810 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vital SignsTM ECG Paper, MAC® Series, 8 years Imaged Archival Life, A4, Red Gri… by AirLife Finland Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0889483TF20041hPaperHH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (2)
- EUDAMED 691627d9-004e-467b-aa83-f1387e8abfd5 61 fields · synced Oct 8, 2026
- FDA UDI 0e30137e-fc5d-40ad-a043-972ac5e3fa31 36 fields · synced May 30, 2026