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Comfort Cough
EUDAMEDClass IIa (EU MDR)
Ref A10002Model SICC2001, SICC2001 PLUSRef A30000
Identity
- Trade Name
- COMFORT COUGH EUDAMED
- Device Name
- Mechanical In-Exsufflator EUDAMED
- Model / Reference
- SICC2001, SICC2001 PLUS EUDAMEDA10002 EUDAMEDA30000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809517011019 EUDAMED08809517011170 EUDAMED
- Basic UDI-DI
- 951701SICC2001WR EUDAMED
- Direct Marketing DI
- 08809517011019 EUDAMED08809517011170 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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 by Seoil Pacific Corp. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 951701SICC2001WR | 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 c5ae1c7a-1df8-41be-bb9d-beca8deedc98 61 fields · synced Jul 31, 2026
- EUDAMED 231d7e9e-8593-4382-a1a1-9c96aff04fc0 61 fields · synced May 18, 2026