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Sign in to claim this brandFLAEM NUOVA SpA
Italy·IT-MF-000007769
Last updated September 17, 2026
What FLAEM NUOVA SpA makes
Flaem Nuova SpA manufactures nasal irrigation sets designed for home use, including single-use and reusable systems for nasal hygiene and sinus care. These devices are intended to help clear nasal passages and alleviate congestion through saline irrigation.
The company’s products are classified as Class I and Class IIa medical devices, with listings in the EU’s EUDAMED database and the FDA’s UDI system. The manufacturer is based in Italy and adheres to relevant European and U.S. regulatory requirements for these device categories.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- Italy
- Address
- 221-223-225, Via Colli storici, San Martino della Battaglia - Desenzano del Garda (BS), Italy
- Website
- www.flaemnuova.it
- —
- —
- [email protected]
- Phone
- 0309910168
- PRRC Contact
- Mauro Gelmetti
- EUDAMED SRN
- IT-MF-000007769
- FDA FEI Number
- —
- DUNS Number
- 431208297
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| P0915em | P0915EM | EUDAMED | Class IIa | Active |
| P0603em | P0603EM | EUDAMED | Class IIa | Active |
| Rf7-1 | RF7-1 | EUDAMED | Class IIa | Active |
| P0513em F1000 Ref 1 | P0513EM F1000 REF 1 | EUDAMED | Class IIa | Active |
| P0318em | P0318EM | EUDAMED | Class IIa | Active |
| Rf9-1 | RF9-1 | EUDAMED | Class IIa | Active |
| FLAEM Rhino Clear Sprint | P0709EM | FDA UDI | Class I | Active |
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