Rocoto Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000045904 FEI 3035371773
Rocoto Inc. is a medical device manufacturer based in the United States, with 18 devices listed in FDA GUDID and EUDAMED (FDA Class I; EU Class I) as of 14 Nov 2026.
- Devices
- 18
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 18
- EUDAMED 6
- Device classes
- FDA Class I 12
- EU Class I 6
- Top EMDN categories
- Sites and related companies
- CEpartner4U authorised representative
- Identifiers
- EUDAMED SRN US-MF-000045904
- FDA FEI 3035371773
- DUNS 960475866
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- CEpartner4UNL
What Rocoto Inc. makes
Rocoto Inc. manufactures reusable device sterilization/disinfection containers, including the SL11 Camera unit, MD 62 System Transmitter, MD 62 System Receiver, MD 11 System Receiver, MD11 System Transmitter, and SL11 Device Sterilizable Cover.
The company's devices are Class I and listed in the eudamed registry. Rocoto Inc. is based in the US.
Catalogue
Search and filter all 18 devicesCompany details
- EUDAMED SRN
- US-MF-000045904
- FDA FEI number
- 3035371773
- DUNS number
- 960475866
- EUDAMED status
- Active
- EUDAMED registered name
- Rocoto Inc.
- Registered address
- 8, Mason, 92618, Irvine (California), United States
- PRRC contact
- Guillermo Dyk
FDA establishments
- Rocoto Ltd. Raanana Central · IL FEI 3014730563
Frequently asked questions
How many devices does Rocoto Inc. have in the registry?
The registry currently lists 18 devices for Rocoto Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rocoto Inc.'s devices?
Among its 18 most recently registered devices, Rocoto Inc. has devices listed in EUDAMED (6 devices) and FDA GUDID (18 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Rocoto Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Rocoto Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Rocoto Inc. in the registry?
The most recently registered devices listed for Rocoto Inc. include Rocoto MD62 Rx Device - MDWL2_B1J1RX, Rocoto MD62 Tx Device - MDWL2_B1J1TX, Rocoto MD11 Rx device - MDWL1_B1J1RX and Rocoto MD11 Tx device - MDWL1_C1N1TX.
Which FDA establishments are linked to Rocoto Inc.?
1 FDA establishment is linked to Rocoto Inc. in the registry; they are listed on the company page.