ZyMot Fertility Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000035741
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- MedEnvoy Global BVNL
What ZyMot Fertility Inc. makes
ZyMot Fertility Inc. manufactures ZyMot Multi devices in two sizes—850µL and 3mL—intended for use in assisted reproductive technologies, including embryo culture and handling.
These devices are classified as Class IIa under EU regulations and are registered in the eudamed database. The company is based in the United States.
Catalogue
ZyMot Multi (850µL) Ref ZMH0850
CE MDR EUDAMEDGUDIDZyMot Multi (3mL) Ref ZMH3000
CE MDR EUDAMEDGUDID
Company details
- EUDAMED SRN
- US-MF-000035741
- EU VAT number
- NL8264.34.277.B01
- EUDAMED status
- Active
- EUDAMED registered name
- ZyMot Fertility Inc.
- Registered address
- 401 Professional Drive, 20879, Gaithersburg, United States
- Website
- www.zymotfertility.com
- [email protected]
- Phone
- +1-240-454-9893
- PRRC contact
- Kevin Sly
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Mar 2029
DNV Product Assurance AS 2460 1 certificate
- C544553 Issued
Quality management system EU MDR
- Issued
- 1 Mar 2024
- Expires
- 1 Mar 2029
Frequently asked questions
How many devices does ZyMot Fertility Inc. have in the registry?
The registry currently lists 2 devices for ZyMot Fertility Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ZyMot Fertility Inc.'s devices?
Among its 2 most recently registered devices, ZyMot Fertility Inc. has devices listed in EUDAMED (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ZyMot Fertility Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for ZyMot Fertility Inc.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for ZyMot Fertility Inc.?
EUDAMED lists 1 certificate for ZyMot Fertility Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2024-03-01.
What are the newest devices from ZyMot Fertility Inc. in the registry?
The most recently registered devices listed for ZyMot Fertility Inc. include ZyMot Multi (850µL) and ZyMot Multi (3mL).