EEG Leads, 0.6m, reusable, 9 pcs
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EEG-ABL. 0,6M, MEHRWEG, 9STK. EUDAMEDEEG Leads, 0.6m, reusable, 9 pcs FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Model / Reference
- 5947804 EUDAMEDFDA UDI1070256K19Z320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098008013 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867521070256K19Z320ST EUDAMED
- 510(k) Number
- K991012 FDA UDI
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- Z12100380 ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable 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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Electrocardiographic lead set, reusable
EEG Leads, 0.6m, reusable, 9 pcs by Draeger Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiographic lead set, reusable.
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Cleared under the same submission
K991012 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
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI 78ef8ed2-6026-4b9c-a932-ccf6cc188556 34 fields · synced Jul 9, 2026
- EUDAMED 2395d389-dd0b-4f01-8f9c-c7295f78e6bf 61 fields · synced Jul 9, 2026