Micromed
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SD LTM 64 PLUS EUDAMEDMicromed FDA UDI
- Generic Name
- Patient monitoring system module, electroencephalographic FDA UDI
- Device Name
- long-term EEG fixed and/or ambulatory acquisition/recording device (64 EEG channels) FDA UDI
- Model / Reference
- SD LTM 64 PLUS EUDAMEDFDA UDI(01)08033928120897 EUDAMED
- Description
- long-term EEG fixed and/or ambulatory acquisition/recording device (64 EEG channels) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928120897 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08033928120897 EUDAMED
- 510(k) Number
- K071782 FDA UDI
- FDA Product Code
- OLV FDA UDIGWQ FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, electroencephalographic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Patient monitoring system module, electroencephalographic
Micromed by Micromed, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, electroencephalographic.
- Sedline™ Monitor — MASIMO CORPORATION · Class II
- RD Sedline — MASIMO CORPORATION · Class II
- X-Series — Advanced Brain Monitoring, Inc. · Class II
- Sedline® Seditation Monitor — MASIMO CORPORATION · Class II
- SedLine — MASIMO CORPORATION · Class II
- RD SedlLine — MASIMO CORPORATION · Class II
- UltraviewSL — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Bispectral Index kit — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K071782 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micromed, Inc.
Sources (2)
- FDA UDI 9ac60138-7a7c-463a-a7fb-f3a331e03f5b 34 fields · synced Jul 15, 2026
- EUDAMED 01e95c61-5362-401b-a795-1d22023362d2 61 fields · synced Jul 15, 2026