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PageWriter TC30 Cardiograph
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 860306510(k) K080999
Identity
- Trade Name
- PageWriter TC30 Cardiograph EUDAMEDPageWriter FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- PageWriter TC30 Cardiograph EUDAMEDPageWriter TC30 FDA UDI
- Model / Reference
- 860306 EUDAMEDPageWriter TC30 Cardiograph FDA UDI
- Description
- PageWriter TC30 FDA UDI
Identifiers
- Catalog Number
- 860306 FDA UDI
- Primary DI / UDI-DI
- 00884838081123 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838081123 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 TC30 Cardiograph by Philips Medical Systems — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080999 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00884838081123 | Class IIa | Active |
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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 (3)
- EUDAMED cc3240ce-05d3-4066-a4f4-a9f42fd9db1f 85 fields · synced Jun 19, 2026
- FDA UDI 3b965dea-5af6-4a80-b3fd-bea523ed1f8f 36 fields · synced May 30, 2026
- FDA 510(k) K080999 1 fields · synced May 18, 2026