Identity
- Trade Name
- MC40 C FDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Model / Reference
- 230V/50Hz KAR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08586014620301 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
- Not 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
No
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
No
FDA UDI
Mc40 C by EKOM spol. s r.o. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K091871 also covers:
- C235 — EKOM spol. s r.o.
- C235 — EKOM spol. s r.o.
- C235 — EKOM spol. s r.o.
- C235 — EKOM spol. s r.o.
- C235 — EKOM spol. s r.o.
- DK50 DS — EKOM spol. s r.o.
- DK50 DS — EKOM spol. s r.o.
- DK50 DS — EKOM spol. s r.o.
- DK50 DS — EKOM spol. s r.o.
- DK50 DS — EKOM spol. s r.o.
- DK50 DS — EKOM spol. s r.o.
- DK50 DS — EKOM spol. s r.o.
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 40edffdf-6d28-427a-8d07-e69b8f943b56 34 fields · synced May 31, 2026