Noctrix Health, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000051469 FEI 3025729280
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Noctrix Health, Inc. makes
Noctrix Health, Inc. manufactures the NTX100 Tonic Motor Activation (NTX100 ToMAc) System, a device designed for motor activation therapy, likely targeting neurological or musculoskeletal conditions by stimulating muscle function.
The NTX100 ToMAc System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Nidra® Charge Dispersing Interface (CDI), Weekly Ref CDI.30D.EU
Regimes: CE MDR Registry: EUDAMEDNidra® Compressive Conductive Garment (CCG), Large Ref NTX.CCGL150.EU
Regimes: CE MDR Registry: EUDAMEDNidra® Compressive Conductive Garment (CCG), Medium Ref NTX.CCGM150.EU
Regimes: CE MDR Registry: EUDAMEDNidra® Charge Dispersing Interface (CDI), Monthly Ref CDI.08D.EU
Regimes: CE MDR Registry: EUDAMEDNTX100 Tonic Motor Activation (NTX100 ToMAc) System Ref DEN220059
Regimes: De Novo Registry: De Novo
Company details
- EUDAMED SRN
- US-MF-000051469
- FDA FEI number
- 3025729280
- EU VAT number
- 83-2225937
- EUDAMED status
- Active
- EUDAMED registered name
- Noctrix Health, Inc.
- Registered address
- 6700, Koll Center Parkway, Suite 310,, CA 94566, Pleasanton, United States
- [email protected]
- PRRC contact
- Jessica Preciado
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 16 Oct 2030
Intertek Medical Notified Body AB 2862 1 certificate
- 28620255134 Active
Quality management system EU MDR
- Issued
- 28 Sep 2026
- Expires
- 16 Oct 2030
Frequently asked questions
How many devices does Noctrix Health, Inc. have in the registry?
The registry currently lists 5 devices for Noctrix Health, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Noctrix Health, Inc.'s devices?
Among its 5 most recently registered devices, Noctrix Health, Inc. has devices listed in EUDAMED (4 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Noctrix Health, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Noctrix Health, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Noctrix Health, Inc.?
EUDAMED lists 1 certificate for Noctrix Health, Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 28 Sep 2026.
What are the newest devices from Noctrix Health, Inc. in the registry?
The most recently registered devices listed for Noctrix Health, Inc. include Nidra® Charge Dispersing Interface (CDI), Weekly, Nidra® Compressive Conductive Garment (CCG), Large, Nidra® Compressive Conductive Garment (CCG), Medium and Nidra® Charge Dispersing Interface (CDI), Monthly.