Identity
- Trade Name
- PageWriter TC70 Cardiograph EUDAMEDPageWriter FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- PageWriter TC30 Cardiograph EUDAMEDPageWriter TC70 Cardiograph FDA UDI
- Model / Reference
- 860315 EUDAMEDPageWriter TC70 Cardiograph FDA UDI
- Description
- PageWriter TC70 Cardiograph FDA UDI
Identifiers
- Catalog Number
- 860315 FDA UDI
- Primary DI / UDI-DI
- 00884838026582 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838026582 EUDAMED
- FDA Product Code
- DPS FDA UDI
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS EUDAMED
- GMDN Term
- Electrocardiograph, professional, multichannel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2340 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
PageWriter TC70 Cardiograph by Philips Medical Systems — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838026582 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 36766152-f94d-40ac-ba11-64a2427bc024 61 fields · synced Jun 8, 2026
- FDA UDI 60ae2c89-8e24-4c09-bfbe-decb221d8c13 36 fields · synced May 29, 2026