Is this your brand? Sign in to claim ownership.
Sign in to claim this brandORMESA SRL
US
Last updated May 23, 2026
What ORMESA SRL makes
Ormesa SRL manufactures manually adjusted assistive ergonomic seating solutions, including postural systems and adaptive chairs designed for long-term use. Their product line also includes non-bariatric manual wheelchairs, push-rim wheelchairs, and attendant-propelled wheelchairs, as well as manual standers for mobility assistance. The company produces ergonomic workdesks, non-powered walkers with handgrips, and pushchairs for caregivers. Examples include the Grillo Adaptive Seating, Trolli wheelchair, and Novus stander.
All listed devices fall under Class I classification in the FDA’s UDI (Unique Device Identification) registry, indicating low-risk, non-invasive mobility and seating aids. The company’s products are registered under the FDA’s UDI system, ensuring traceability and compliance with U.S. medical device regulations. Ormesa SRL operates from 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 medical devices does Ormesa SRL manufacture?
Ormesa SRL specializes in manually adjusted assistive devices primarily focused on mobility and seating support. Their product line includes manually-adjusted ergonomic chairs, non-bariatric manual wheelchairs (such as push-rim and attendant-propelled models), adaptive seating systems, manual standers, ergonomic workdesks, non-powered walkers with handgrips, and caregiver pushchairs. These devices are designed for long-term use and address functional needs in clinical, home, or workplace settings.
Where is Ormesa SRL based, and what does that mean for their regulatory standing?
Ormesa SRL is based in the United States, which means their devices are subject to U.S. regulatory requirements. The company’s products are registered under the FDA’s UDI (Unique Device Identification) system, ensuring compliance with U.S. medical device regulations. Registration in the UDI system helps track and verify the devices’ identity and traceability, but it does not imply approval or clearance for individual products.
Which regulatory registries list Ormesa SRL’s devices, and why is this important?
Ormesa SRL’s devices are listed in the FDA’s UDI (Unique Device Identification) system. This registry is critical because it provides a standardized way to identify medical devices, ensuring transparency in the supply chain, facilitating recalls if needed, and supporting compliance with U.S. regulations. Listing in the UDI system helps healthcare providers, regulators, and manufacturers track devices throughout their lifecycle.
How are Ormesa SRL’s devices classified under U.S. regulations, and what does that classification indicate?
All of Ormesa SRL’s listed devices fall under Class I classification in the FDA’s UDI system. This classification applies to low-risk devices, such as manually adjusted mobility aids and seating solutions, which pose minimal potential harm to users. Class I devices typically undergo general controls (e.g., manufacturing practices, labeling requirements) rather than pre-market approval, as they are considered safe and effective for their intended use without stringent pre-market review.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 432070019
Catalogue (141)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Juditta | JUDITTA-40 B60 LIGHT GREY, BLACK FRAME, WITH MANUAL BRAKES FOR THE CARE GIVER | FDA UDI | Class I | Active |
| Juditta | JUDITTA-45 B60 LIGHT GREY, WHITE FRAME, WITH MANUAL BRAKES FOR THE CARE GIVER | FDA UDI | Class I | Active |
| Juditta | JUDITTA-45 B60 LIGHT GREY, BLACK FRAME | FDA UDI | Class I | Active |
| Juditta | JUDITTA-45 B30 DARK GREY, BLACK FRAME | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING BLU mis. mini con 865 poggiatesta imbottito | FDA UDI | Class I | Active |
| Juditta | JUDITTA-50 B30 LIGHT GREY, BLACK FRAME | FDA UDI | Class I | Active |
| Juditta | JUDITTA-50 B60 DARK GREY, WHITE FRAME, WITH MANUAL BRAKES FOR THE CARE GIVER | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING ROSA mis. SMALL con 835 poggiatesta imbottito, sagomato | FDA UDI | Class I | Active |
| Juditta | JUDITTA-45 B30 LIGHT GREY, BLACK FRAME | FDA UDI | Class I | Active |
| Juditta | JUDITTA-45 B60 DARK GREY, WHITE FRAME, WITH MANUAL BRAKES FOR THE CARE GIVER | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING ROSA mis. mini con 865 poggiatesta imbottito | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING ROSA mis. SMALL con 863 poggiatesta posturale | FDA UDI | Class I | Active |
| Trollino | TROLLINO PINK with 951 Height adjustable push handles | FDA UDI | Class I | Active |
| Juditta | JUDITTA-40 B30 LIGHT GREY, BLACK FRAME | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-MINI 856 CUSC.BROWN | FDA UDI | Class I | Active |
| Trolli | TROLLI T60 size 36 WITH SELF- PROPELLING WHEELS with 951 Height adjustable push | FDA UDI | Class I | Active |
| Trolli | TROLLI T60 MIS.40 DA AUTOSPINTA | FDA UDI | Class I | Active |
| Juditta | JUDITTA-45 B60 DARK GREY, WHITE FRAME | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-S 869 CUSC.BLUE | FDA UDI | Class I | Active |
| Juditta | JUDITTA-50 B30 DARK GREY, BLACK FRAME | FDA UDI | Class I | Active |
| Juditta | JUDITTA-50 B60 LIGHT GREY, BLACK FRAME, WITH MANUAL BRAKES FOR THE CARE GIVER | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-M 869 CUSC.PINK | FDA UDI | Class I | Active |
| Clip | CLIP-4 | FDA UDI | Class I | Active |
| Clip | CLIP-3 | FDA UDI | Class I | Active |
| Mini Standy | MINI STANDY-2 | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-MINI SEATING UNIT. BLUE | FDA UDI | Class I | Active |
| Juditta | JUDITTA-40 B60 DARK GREY, WHITE FRAME | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-M SEATING UNIT. BROWN | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-MINI 856 CUSC.PINK | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING ROSA mis. mini con 863 poggiatesta posturale | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING ROSSO mis. MEDIUM con 865 poggiatesta imbottito | FDA UDI | Class I | Active |
| Trollino | TROLLINO BLACK with 951 Height adjustable push handles | FDA UDI | Class I | Active |
| Trolli | TROLLI T30 MIS.43 | FDA UDI | Class I | Active |
| Trolli | TROLLI T60 size 40 WITH SELF- PROPELLING WHEELS with 951 Height adjustable push | FDA UDI | Class I | Active |
| Juditta | JUDITTA-40 B30 LIGHT GREY, WHITE FRAME | FDA UDI | Class I | Active |
| Multifunction Table | TAVOLO MULTIFUNZIONE MIS LARGE | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-MINI SEATING UNIT. PINK | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-S 856 CUSC.BROWN | FDA UDI | Class I | Active |
| Multifunction Table | TAVOLO MULTIFUNZIONE MIS MEDIUM | FDA UDI | Class I | Active |
| Grillo Chair | GRILLO CHAIR BLU mis.MEDIUM | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-MINI 856 CUSC.BLUE | FDA UDI | Class I | Active |
| Juditta | JUDITTA-45 B60 LIGHT GREY, BLACK FRAME, WITH MANUAL BRAKES FOR THE CARE GIVER | FDA UDI | Class I | Active |
| Juditta | JUDITTA-40 B30 DARK GREY, BLACK FRAME | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING ROSSO mis. MEDIUM con 863 poggiatesta posturale | FDA UDI | Class I | Active |
| Dynamico | DYNAMICO-2 OUTDOOR USE | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-M SEATING UNIT. PINK | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-S 869 CUSC.BROWN | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING BLU mis. mini con 835 poggiatesta imbottito, sagomato e | FDA UDI | Class I | Active |
| Grillo Postural System | GRILLO P.SYS-MINI SEATING UNIT. BROWN | FDA UDI | Class I | Active |
| Grillo Adaptive Seating | GRILLO ADAPTIVE SEATING BLU mis. SMALL con 863 poggiatesta posturale | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.