Identity
- Trade Name
- Thermal Array Recorder Paper, 10 RL EUDAMEDPaper FDA UDI
- Generic Name
- Electrocardiographic recording paper FDA UDI
- Device Name
- Physiological Signal Recording Paper EUDAMED10 Rolls Thermal Array Recorder Paper FDA UDI
- Model / Reference
- 40477A EUDAMEDThermal Array Recorder Paper, 10 RL FDA UDI
- Description
- 10 Rolls Thermal Array Recorder Paper FDA UDI
Identifiers
- Catalog Number
- 40477A FDA UDI
- Primary DI / UDI-DI
- 10884838001166 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM336SW EUDAMED
- Unit of Use DI
- 00884838001169 EUDAMED
- FDA Product Code
- DSF FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Electrocardiographic recording paper FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.2810 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Thermal Array Recorder Paper, 10 RL by Philips Medical Systems — Class I — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM336SW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 09e10cc7-930a-4a23-8adc-93a9a95a2979 61 fields · synced Aug 4, 2026
- FDA UDI c05917dd-6a93-4ca6-8e9a-4bdfc1a7a882 37 fields · synced May 29, 2026