Identity
- Trade Name
- DK50 DS EUDAMEDFDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Device Name
- Medical compressor EUDAMED
- Model / Reference
- DK50 DS EUDAMED499000320-000 EUDAMEDBAS NOZ UL 120V/60Hz UL 3bar NO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08586014622572 EUDAMED08586014620813 FDA UDI
- Basic UDI-DI
- B-08586014622572 EUDAMED
- FDA Product Code
- BTI FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Medical device air compressor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.6250 FDA UDI
- Market of Registration
- Slovakia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device air compressor
Dk50 Ds by EKOM spol. s r.o. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI 06bbdaca-b6b9-4abd-943c-d1201afd8972 32 fields · synced Jul 8, 2026
- EUDAMED a50b7b11-1e09-4d5f-b900-595a2fb462cb 61 fields · synced Jul 8, 2026