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resi IMT Inspiratory muscle trainer resi
EUDAMEDFDA UDIClass I (EU MDR)
Ref IMT1
by Anel AG
Identity
- Trade Name
- Whole Blood Calibrator Set FDA UDI
- Generic Name
- Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- resi IMT Inspiratory muscle trainer resi EUDAMED6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Immunosuppressants FDA UDI
- Model / Reference
- IMT1 EUDAMED28039/XL FDA UDI
- Description
- 6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Immunosuppressants FDA UDI
Identifiers
- Catalog Number
- 28039/XL FDA UDI
- Primary DI / UDI-DI
- 04250317521637 EUDAMEDFDA UDI
- Basic UDI-DI
- 0764037203imt1AG EUDAMED
- Direct Marketing DI
- 04250317521637 EUDAMED
- FDA Product Code
- JIX FDA UDI
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
- GMDN Term
- Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 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
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
resi IMT Inspiratory muscle trainer resi by Anel AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0764037203imt1AG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Anel AG
- EUDAMED SRN
- CH-MF-000033240
- Authorised Representative
- Basmed GmbH DE-AR-000049709
Sources (2)
- EUDAMED 7bdefb6f-0a55-4be4-9713-78066206cf73 61 fields · synced Jun 18, 2026
- FDA UDI 0798dfa4-bb4e-46a5-a8c2-c67695fd38ed 37 fields · synced May 29, 2026