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Serena Nylon ema

FDA UDI

Class II (US FDA UDI)

by Serena Sleep Solutions Llc

Identity

Trade Name
Serena Nylon ema FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
ema sleep apnea appliances FDA UDI
Model / Reference
Nylon ema FDA UDI
Description
ema sleep apnea appliances FDA UDI

Identifiers

Primary DI / UDI-DI
00860005753055 FDA UDI
510(k) Number
K203606 FDA UDI
FDA Product Code
LRK FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

Serena Nylon ema by Serena Sleep Solutions Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Cleared under the same submission

K203606 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Serena Sleep Solutions Llc

Sources (1)

  • FDA UDI af45a892-aacf-4679-85c8-09216bf18e70 34 fields · synced May 30, 2026