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1-Channel Chemical Thermal Paper, Gray
EUDAMEDFDA UDIClass I (EU MDR)
Ref 40457C
Identity
- Trade Name
- 1-CHANNEL CHEMICAL THERMAL PAPER, GRAY EUDAMEDPaper FDA UDI
- Generic Name
- Electrocardiographic recording paper FDA UDI
- Device Name
- Physiological Signal Recording Paper EUDAMED1-Channel Chemical Thermal Paper, Gray FDA UDI
- Model / Reference
- 40457C EUDAMED1-CHANNEL CHEMICAL THERMAL PAPER, GRAY FDA UDI
- Description
- 1-Channel Chemical Thermal Paper, Gray FDA UDI
Identifiers
- Catalog Number
- 40457C FDA UDI
- Primary DI / UDI-DI
- 00884838001121 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM336SW EUDAMED
- Unit of Use DI
- 10884838001128 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
- 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
1-Channel Chemical Thermal Paper, Gray 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 9013da3f-7090-4393-9553-f7e844dc6fc1 61 fields · synced Jul 20, 2026
- FDA UDI d84e451a-d3d1-4ece-b243-65af353d748b 36 fields · synced May 30, 2026