Identity
- Trade Name
- Mesire™ EUDAMEDMesire™ Sinus Balloon catheter EUDAMEDMesireTM Sinus Balloon Catheter FDA UDI
- Generic Name
- Nasal/paranasal balloon catheter FDA UDI
- Device Name
- Mesire™ Sinus Balloon Catheter EUDAMEDMesireTM Sinus Balloon Catheter, 7.00 mm x 17 mm FDA UDI
- Model / Reference
- MSB70017 EUDAMEDFDA UDI
- Description
- MesireTM Sinus Balloon Catheter, 7.00 mm x 17 mm FDA UDI
Identifiers
- Catalog Number
- MSB70017 FDA UDI
- Primary DI / UDI-DI
- 18904224901480 EUDAMEDFDA UDI
- Basic UDI-DI
- B-18904224901480 EUDAMED89042249SBD2W EUDAMED
- Direct Marketing DI
- 18904224901480 EUDAMED
- 510(k) Number
- K172737 FDA UDI
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- Q030199 NASOPHARYNGEAL DEVICES - OTHER EUDAMED
- GMDN Term
- Nasal/paranasal balloon catheter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
No
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
- Length — 17 Millimeter FDA UDIOuter Diameter — 7.00 Millimeter FDA UDI
Mesire™ by Meril Life Sciences Pvt. Ltd. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-18904224901480 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-18904224901480 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000008308
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED c3749cca-ebc8-4ee2-8aa9-bccd63e68ea6 61 fields · synced Jun 19, 2026
- FDA UDI 381011b9-13da-4f72-857e-1baea6f31291 38 fields · synced May 30, 2026
- EUDAMED 2d1ad04e-837a-4808-a82f-11f2e4753e27 61 fields · synced Jun 19, 2026