Embla Bedside Unit Bracket
by Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek)
Ref 2040001
Embla Bedside Unit Bracket (2040001) is a device classified as Class I in the EU and Class II in the US made by Natus Medical Incorporated Dba Excel-Tech Ltd (Xltek), registered in EUDAMED on 11 Mar 2026 (Basic UDI-DI 038283NA00025E3), cleared under FDA 510(k) K111742 on 31 Aug 2011 and listed in FDA GUDID since 27 Feb 2025 (UDI-DI 00382830023986), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number038283NA00025E3 00382830023986 | Date11 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00382830023986 | Date27 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK111742 | Date31 Aug 2011 | StatusActive |
Official records
- EUDAMED public site 038283NA00025E3
- AccessGUDID record 00382830023986
- FDA 510(k) database K111742
Across registries
- EUDAMED Basic UDI-DI 038283NA00025E3 registered 11 Mar 2026 Active
- FDA 510(k) K111742 decided 31 Aug 2011 Active
- FDA GUDID UDI-DI 00382830023986 listed 27 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K111742
- Listed FDA GUDID 00382830023986
- Registered EUDAMED 038283NA00025E3
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Embla Bedside Unit Bracket EUDAMEDNatus GUDID
- Generic name
- Polysomnograph
- Device name
- MDrive Accessories
- Model / reference
- 2040001
- Primary DI / UDI-DI
- 00382830023986
- Basic UDI-DI
- 038283NA00025E3
- Direct marketing DI
- 00382830023986
- FDA product code
- MNR
- EMDN code
- Z12100580 Polysomnography instruments - hardware accessories
- GMDN term
- Polysomnograph
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 868.2375
- EU registration type
- Standard device
- EU market of registration
- Ireland
- GUDID distribution status
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
| Contains latex | No | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Contains latex UDI-DI 00382830023986: EUDAMED states No, FDA GUDID states Yes.
Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
Manufacturer details
- EUDAMED SRN
- CA-MF-000004001
- Authorised representative
- Natus Manufacturing Ltd IE-AR-000000884
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