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tremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EU
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 102110
Identity
- Trade Name
- tremoflo C-100 Kit - Ganshorn - EU Edition EUDAMEDtremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EU FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- tremoflo C-100 Kit - Ganshorn - EU Edition EUDAMEDThe tremoflo C-100 Airwave Oscillometry System and Accessories - Ganshorn EU Edition is a Ganshorn OEM tremoflo C-100 compatible with a GVS PFT filter. FDA UDI
- Model / Reference
- 102110 EUDAMEDFDA UDI
- Description
- The tremoflo C-100 Airwave Oscillometry System and Accessories - Ganshorn EU Edition is a Ganshorn OEM tremoflo C-100 compatible with a GVS PFT filter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261021107 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07540261021107 EUDAMED
- FDA Product Code
- PNV FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Pulmonary function analysis system, adult FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary function analysis system, adult
tremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EU by Thorasys Thoracic Medical Systems Inc — Class II — MDD, FDA UDI — listed in FDA…
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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
- Thorasys Thoracic Medical Systems Inc
Sources (2)
- FDA UDI da39ba83-d95a-423b-a5fc-3b934180b02d 33 fields · synced Jun 19, 2026
- EUDAMED 11c5ac30-1ed3-45b4-a8a6-4f2c01d16392 61 fields · synced Jun 19, 2026