Electrode, limb clamp Icon/C400 4/bx
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Electrode, limb clamp Icon/C400 4/bx EUDAMEDNOUN FDA UDI
- Generic Name
- Electrocardiographic electrode, reusable FDA UDI
- Device Name
- Limb Clamp Electrode EUDAMEDElectrode,limb clamp Icon/C400 4/bx FDA UDI
- Model / Reference
- Limb Clamp Electrode EUDAMED989803101691 EUDAMEDElectrode, limb clamp Icon/C400 4/bx FDA UDI
- Description
- Electrode,limb clamp Icon/C400 4/bx FDA UDI
Identifiers
- Catalog Number
- 989803101691 FDA UDI
- Primary DI / UDI-DI
- 00884838117174 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1858NG EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 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
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Electrocardiographic lead set, reusable
Electrode, limb clamp Icon/C400 4/bx by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Electrocardiographic lead set, reusable.
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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 | 0884838BM1858NG | 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 6e4a0c40-0782-46f7-be6c-8e1320474fea 61 fields · synced Jun 18, 2026
- FDA UDI dc67e68e-e567-48ff-b027-af245ae25f84 35 fields · synced May 27, 2026