C235

FDA UDI

Class II (US FDA UDI)

by EKOM spol. s r.o.

Identity

Trade Name: C235 FDA UDI
Generic Name: Medical device air compressor FDA UDI
Model / Reference: C235 FDA UDI

Identifiers

Primary DI / UDI-DI: 08586014620127 FDA UDI
510(k) Number: K091871 FDA UDI
FDA Product Code: BTI FDA UDI
GMDN Term: Medical device air compressor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.6250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Medical device air compressor

C235 by EKOM spol. s r.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K091871 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: EKOM spol. s r.o.

Sources (1)

FDA UDI 4f3ae205-3fbe-4728-960c-cd582af6afdb 33 fields · synced Jun 8, 2026