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Sicat Optisleep

FDA UDI

Class II (US FDA UDI)

by SiCAT GmbH & Co. KG

Identity

Trade Name
SICAT OPTISLEEP FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Model / Reference
V1.1 FDA UDI

Identifiers

Catalog Number
10401 FDA UDI
Primary DI / UDI-DI
D776OSLEEPV110 FDA UDI
510(k) Number
K153291 FDA UDI
FDA Product Code
LRK FDA UDI
LQZ 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

Sicat Optisleep by SiCAT GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SiCAT GmbH & Co. KG

Sources (1)

  • FDA UDI 0e424d27-c96e-4886-87c1-d039171797ab 35 fields · synced May 30, 2026