Identity
- Trade Name
- 12L Leadset, Snaps, IEC EUDAMEDNOUN FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- 12L Leadset, Grabber/Snaps IEC; EUDAMEDStandard-length leadset for Stress system. 10-lead, IEC color-coding, snaps FDA UDI
- Model / Reference
- 989803180151 EUDAMED12L Leadset, Snaps, IEC FDA UDI
- Description
- Standard-length leadset for Stress system. 10-lead, IEC color-coding, snaps FDA UDI
Identifiers
- Catalog Number
- 989803180151 FDA UDI
- Primary DI / UDI-DI
- 00884838029149 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM507SZ EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z12050101 STRESS ANALYSIS SYSTEMS EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class IIa 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
12L Leadset, Snaps, IEC by Philips Medical Systems — Class IIa — 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 | 0884838BM507SZ | 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 Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 1ffb8735-3516-4204-b59a-adff5052d3eb 61 fields · synced Jun 17, 2026
- FDA UDI d554d1cf-7263-419f-8e52-05bf92ab948e 36 fields · synced May 30, 2026