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tremoflo C-100 Kit Vitalograph - Healthcare Edition
EUDAMEDClass IIa (EU MDR)
Ref 101762
Identity
- Trade Name
- tremoflo C-100 Kit Vitalograph - Healthcare Edition EUDAMED
- Device Name
- tremoflo C-100 Kit Vitalograph - Healthcare Edition EUDAMED
- Model / Reference
- 101762 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540261017629 EUDAMED
- Basic UDI-DI
- B-07540261017629 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 C-100 Kit Vitalograph - Healthcare Edition 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-07540261017629 | 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 bee39fb1-2f65-4b5e-8c19-6eff520002f1 61 fields · synced Oct 6, 2026