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Comfort Cough Ii
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref P20000Model CC20, CC20P
Identity
- Trade Name
- COMFORT COUGH II EUDAMED
- Device Name
- Mechanical In-Exsufflator EUDAMED
- Model / Reference
- CC20, CC20P EUDAMEDP20000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809517011514 EUDAMED
- Basic UDI-DI
- 951701ComfortCoughN6 EUDAMED
- Direct Marketing DI
- 08809517011514 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Comfort Cough Ii by Seoil Pacific Corp. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113549 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 951701ComfortCoughN6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Seoil Pacific Corp.
- EUDAMED SRN
- KR-MF-000012478
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED c6e79b19-b003-4274-9f14-e0c193fc8231 61 fields · synced Jun 19, 2026
- FDA 510(k) K113549 1 fields · synced May 18, 2026