12L Leadset, 4mm banana IEC
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- 12L Leadset, 4mm banana IEC EUDAMEDLeads FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Wireless PIM leadwires, 3mm AAMI/4mm IEC EUDAMEDWireless PIM Leadwires for PageWriter TC Series Cardiographs,10-lead, IEC color-coding, 4mm banana FDA UDI
- Model / Reference
- Wireless PIM leadwires, 3mm AAMI/4mm IEC EUDAMED989803223961 EUDAMED12L Leadset, 4mm banana IEC FDA UDI
- Description
- Wireless PIM Leadwires for PageWriter TC Series Cardiographs,10-lead, IEC color-coding, 4mm banana FDA UDI
Identifiers
- Catalog Number
- 989803223961 FDA UDI
- Primary DI / UDI-DI
- 00884838126428 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1818N4 EUDAMED
- FDA Product Code
- DPS 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
- 870.2340 FDA UDI
- Market of Registration
- Germany 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
No
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
12L Leadset, 4mm banana IEC by Philips Medizin Systeme Böblingen GmbH — 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 | 0884838BM1818N4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED f2085727-1732-4393-a92d-47284eb97e76 61 fields · synced Jul 11, 2026
- FDA UDI 1448118f-237b-4157-a87c-69f6052a4cb2 35 fields · synced May 29, 2026