Identity
- Trade Name
- Narcotrend Patient lead PKM4 EUDAMEDNarcotrend Patient lead FDA UDI
- Generic Name
- Electroencephalographic monitoring system FDA UDI
- Device Name
- Narcotrend Patient lead EUDAMED2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063) FDA UDI
- Model / Reference
- EK-0306 EUDAMEDPKM4 FDA UDI
- Description
- 2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260497025016 EUDAMEDFDA UDI
- Basic UDI-DI
- 426049702Patientlead_PKK5 EUDAMED
- Direct Marketing DI
- 04260497025016 EUDAMED
- 510(k) Number
- K033543 FDA UDI
- FDA Product Code
- OMC FDA UDIOLW FDA UDIOLT FDA UDI
- EMDN Code
- Z12100380 ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electroencephalographic monitoring system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 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
No
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
Yes
Category: Electroencephalographic monitoring system
Narcotrend Patient lead by Mt Monitortechnik GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K033543 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mt Monitortechnik GmbH & Co. KG
Sources (2)
- FDA UDI 6a7bda63-cf65-47a6-ac31-79266df12512 35 fields · synced Jun 18, 2026
- EUDAMED 9a8f113c-d53e-4849-93da-0959627a8533 61 fields · synced Jun 18, 2026