Identity
- Trade Name
- tremoflo Molded Test Load 15R - Characterized EUDAMEDtremoflo C2 Reference Test Load FDA UDI
- Generic Name
- Pulmonary function analysis system, adult FDA UDI
- Device Name
- tremoflo EUDAMEDThe tremoflo C2 Reference Test Load (model 101947) is used for field calibration of the tremoflo C2. FDA UDI
- Model / Reference
- 101947 EUDAMEDFDA UDI
- Description
- The tremoflo C2 Reference Test Load (model 101947) is used for field calibration of the tremoflo C2. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540261019470 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540261tremofloC2N6 EUDAMED
- FDA Product Code
- PNV FDA UDI
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Pulmonary function analysis system, adult
tremoflo C2 Reference Test Load by Thorasys Thoracic Medical Systems Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 40c70a9b-81f1-4888-a199-be3650c20318 34 fields · synced Jun 20, 2026
- EUDAMED 895defd8-e4ff-4761-a1d4-b4a21b153264 61 fields · synced Jun 20, 2026