Tc Additional Long Leads Kit: Iec
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- TC ADDITIONAL LONG LEADS KIT: IEC EUDAMEDNOUN FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- TC 10, TC20, TC30, TC50, TC70 lead sets EUDAMEDLong Upgrade Kit 12-15/16 leads IEC color coded for PageWriter TC70. Consisting of 4 additional long lead assy (48" (1,22m)), 6 shorting plugs, 2 lead separators 3.4 DIA, 4 banana post adapters, 6 colored clips, 6 colored rings, 4 white base rings and instructions for use.The long additions lead sets come pre-assembled with the white base ring and the banana post adapters. 1 kit = 1 sales unit. FDA UDI
- Model / Reference
- 989803151781 EUDAMEDTC ADDITIONAL LONG LEADS KIT: IEC FDA UDI
- Description
- Long Upgrade Kit 12-15/16 leads IEC color coded for PageWriter TC70. Consisting of 4 additional long lead assy (48" (1,22m)), 6 shorting plugs, 2 lead separators 3.4 DIA, 4 banana post adapters, 6 colored clips, 6 colored rings, 4 white base rings and instructions for use.The long additions lead sets come pre-assembled with the white base ring and the banana post adapters. 1 kit = 1 sales unit. FDA UDI
Identifiers
- Catalog Number
- 989803151781 FDA UDI
- Primary DI / UDI-DI
- 00884838015005 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM511SQ EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrocardiographic lead set, reusable
Tc Additional Long Leads Kit: Iec by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM511SQ | 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 e2bc337c-fc24-4a3d-b2dd-98ee56664a9d 61 fields · synced Jul 11, 2026
- FDA UDI 7ff82752-efc8-49dd-b7a9-7a8acb6a6464 36 fields · synced May 30, 2026