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Sign in to claim this brandOmnia Spa
US
Last updated May 23, 2026
What Omnia Spa makes
Omnia Spa manufactures single-use surgical drapes, surgical gowns, surgical caps, and face masks for use in medical procedures. The company also produces polyolefin/fluoropolymer monofilament sutures, disposable surgical irrigation/aspiration systems, and dental suction system cannulas, all designed for one-time use in clinical settings.
These devices are classified as Class I or Class II medical devices and are listed in the FDA’s 510(k) and UDI registries. Omnia Spa is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of devices does Omnia Spa manufacture?
Omnia Spa manufactures single-use surgical drapes, surgical gowns, surgical caps, face masks, polyolefin/fluoropolymer monofilament sutures, disposable surgical irrigation/aspiration systems, and dental suction system cannulas. These products are designed for one-time use in clinical settings, as stated in the summary provided in the device data.
Where is Omnia Spa based?
Omnia Spa is based in the United States, as explicitly stated in the summary section of the device data, which identifies the company's country as US.
In which regulatory registries are Omnia Spa's devices listed?
Omnia Spa's devices are listed in the FDA’s 510(k) and UDI registries, as specified in the LISTED IN field of the device data, which includes fda_510k and fda_udi.
How are Omnia Spa's devices classified?
Omnia Spa's devices are classified as Class I or Class II medical devices, as indicated in the DEVICE CLASSES field of the device data, which lists both Class I and Class II as the classification categories for the company's products.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (194)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sterile PTFE Surgical Suture | PSNPTFE8 | FDA UDI | Class II | Active |
| Infusion Sets, Bien Air | 32.F0260.00 | FDA UDI | Class I | Active |
| Omnicap | 10.M0017.00 | FDA UDI | Class I | Active |
| Surgical Sterile Drape | 12.A1028.00 | FDA UDI | Class II | Active |
| Sterile PTFE Surgical Suture | 32.Z4400.00 | FDA UDI | Class II | Active |
| Expo model gown (length 135 cm) size XXL | 30.D1277.00 | FDA UDI | Class I | Active |
| Omnisleeve | 22.U0007.00 | FDA UDI | Class I | Active |
| Sterile PTFE Surgical Suture | 32.Z3150.00 | FDA UDI | Class II | Active |
| Surgical Sterile Drape | 12.T4355.00 | FDA UDI | Class II | Active |
| Sterile PTFE Surgical Suture | 32.Z4401.00 | FDA UDI | Class II | Active |
| Sterile PTFE Surgical Suture | 32.Z3161.00 | FDA UDI | Class II | Active |
| Surgical Sterile Drape | 12.T1791.00 | FDA UDI | Class II | Active |
| Sterile PTFE Surgical Suture | PSNPTFE1SPL | FDA UDI | Class II | Active |
| Surgical Sterile Drape | 12.T2360.00 | FDA UDI | Class II | Active |
| Sterile PTFE Surgical Suture | 32.Z3151.00 | FDA UDI | Class II | Active |
| Sterile PTFE Surgical Suture | PSNPTFE11SPL | FDA UDI | Class II | Active |
| Surgical Sterile Drape | 22.T1782.00 | FDA UDI | Class II | Active |
| Surgical Sterile Drape | 12.T1780.00 | FDA UDI | Class II | Active |
| Punches, NOBEL | 32.Z2004.00 | FDA UDI | Class I | Active |
| Yellow gown with cuffs (length 120 cm) | 30.D1304.00 | FDA UDI | Class I | Active |
| Expo model gown (length 118 cm) size S | 22.D1278.00 | FDA UDI | Class I | Active |
| Sterile PTFE Surgical Suture | PSNPTFE6 | FDA UDI | Class II | Active |
| Essential Surgical | 30.D2304.00 | FDA UDI | Class II | Active |
| Surgical Sterile Drape | 12.T1781.00 | FDA UDI | Class II | Active |
| Sterile Aspiration Tips | 22.F6061.00 | FDA UDI | Class I | Active |
| Surgical Sterile Drape | 12.T1354.00 | FDA UDI | Class II | Active |
| Surgical aspirator 2.20 m with Yankauer suction tip, with aspiration control | 32.F2044.00 | FDA UDI | Class I | Active |
| Punches, NOBEL | 32.Z2007.00 | FDA UDI | Class I | Active |
| Universal seat cover and backrest cover Shell Cover | 20.O0105.00 | FDA UDI | Class I | Active |
| Sterile PTFE Surgical Suture | PSNPTFE7 | FDA UDI | Class II | Active |
| Sterile PTFE Surgical Suture | PSNPTFE11 | FDA UDI | Class II | Active |
| Surgical Sterile Drape | 12.T4370.00 | FDA UDI | Class II | Active |
| Omnicap | 30.M0002.00 | FDA UDI | Class I | Active |
| Irrigation line, W&H | 32.F0081.00 | FDA UDI | Class I | Active |
| Green gown with cuffs (length 120 cm) | 22.D1006.00 | FDA UDI | Class I | Active |
| Surgical Sterile Drape | 12.T1371.00 | FDA UDI | Class II | Active |
| Implant Kit | 12.XYYYY.00 | FDA UDI | Class II | Active |
| Punches, NOBEL | 32.Z2008.00 | FDA UDI | Class I | Active |
| Face Masks | 30.M1302.00 | FDA UDI | Class II | Active |
| Surgical Sterile Drape | 12.T4368.00 | FDA UDI | Class II | Active |
| Sterile PTFE Surgical Suture | PSNPTFE3 | FDA UDI | Class II | Active |
| Surgical Procedure Packs | K110724 | FDA 510(k) | Class II | Active |
| Ptfe Surgical Suture | K132464 | FDA 510(k) | Class II | Active |
| Ptfe Surgical Suture | K180630 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Omnia Srl FIDENZA Parma · IT FEI 3004361903