Identity
- Trade Name
- 3 Leadset, Snap, AAMI, ICU EUDAMEDCBL 3 Leadset, Snap, AAMI, ICU EUDAMEDECG Cables and Leadsets FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG Lead Sets EUDAMED3 Leadset, Snap, AAMI, ICU FDA UDI
- Model / Reference
- 989803145111 EUDAMEDCBL 3 Leadset, Snap, AAMI, ICU FDA UDI
- Description
- 3 Leadset, Snap, AAMI, ICU FDA UDI
Identifiers
- Catalog Number
- 989803145111 FDA UDI
- Primary DI / UDI-DI
- 00884838123427 EUDAMED00884838021310 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM556TE EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMEDZ1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
3 Leadset, Snap, AAMI, ICU by Philips Medizin Systeme Böblingen GmbH — Class I — 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 | 0884838BM556TE | 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 (3)
- EUDAMED 9fa98e05-72f4-4792-8664-74342603ed60 61 fields · synced Oct 5, 2026
- EUDAMED 4efa03b7-2bbf-4c35-b830-486133efa439 61 fields · synced May 17, 2026
- FDA UDI 9e854553-c264-4b9c-a5b0-7a472370436e 36 fields · synced May 30, 2026