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tremoflo C100 Airwave Oscillometry System Unit - Lemon PFT filter compatible
EUDAMEDClass IIa (EU MDR)
Ref 101596
Identity
- Trade Name
- tremoflo C100 Airwave Oscillometry System Unit - Lemon PFT filter compatible EUDAMED
- Device Name
- tremoflo C100 Airwave Oscillometry System Unit - Lemon PFT filter compatible EUDAMED
- Model / Reference
- 101596 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540261015960 EUDAMED
- Basic UDI-DI
- B-07540261015960 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
tremoflo C100 Airwave Oscillometry System Unit - Lemon PFT filter compatible by Thorasys Thoracic Medical Systems Inc. — Class IIa — MDD — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07540261015960 | Class IIa | Active |
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Manufacturer
- Manufacturer
- THORASYS Thoracic Medical Systems Inc.
- EUDAMED SRN
- CA-MF-000039221
- Authorised Representative
- OMC NI MEDICAL LIMITED XI-AR-000019483
Sources (1)
- EUDAMED 51391ff8-86a6-45d0-87d3-e47d3fe64dbc 61 fields · synced Jun 18, 2026