ECG MonoLead 5, AHA/US 5.3m
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EKG MonoLead, 5-adrig, AHA/US, 5,3m EUDAMEDECG MonoLead 5, AHA/US 5.3m FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Model / Reference
- MP05133 EUDAMEDFDA UDI1080266K15L000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675634737 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867511080266K15L000N5 EUDAMED
- Direct Marketing DI
- 04048675634737 EUDAMED
- FDA Product Code
- IKD FDA UDI
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES 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
- 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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiographic lead set, reusable
ECG MonoLead 5, AHA/US 5.3m by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI bfc811c6-08ce-4068-b6d6-241dcfb82519 32 fields · synced Sep 18, 2026
- EUDAMED d8c13cab-4892-4192-aaa8-f80f9d0870b6 61 fields · synced Sep 18, 2026