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CBL 5 Lead Snap Chest AAMI, ICU
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803144911
Identity
- Trade Name
- CBL 5 Lead Snap Chest AAMI, ICU EUDAMEDECG Cables and Leadsets FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG Lead Sets EUDAMED5 Lead Snap Chest AAMI, ICU FDA UDI
- Model / Reference
- 989803144911 EUDAMEDCBL 5 Lead Snap Chest AAMI, ICU FDA UDI
- Description
- 5 Lead Snap Chest AAMI, ICU FDA UDI
Identifiers
- Catalog Number
- 989803144911 FDA UDI
- Primary DI / UDI-DI
- 00884838021259 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM556TE EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z1203020299 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
CBL 5 Lead Snap Chest 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 (2)
- EUDAMED 5ac66b12-e54b-412e-b7ea-f2fc514d8727 61 fields · synced Jun 19, 2026
- FDA UDI 98e8b23f-f837-4494-a2f3-369285226b76 36 fields · synced May 30, 2026