Staclear, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000044904 FEI 3026478941
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
What Staclear, Inc. makes
Staclear, Inc. manufactures StaClear syringes, including models SC250AN, SC250LS, and SC250LL.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
- Registry: GUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: CE MDR Registry: EUDAMEDGUDID
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000044904
- FDA FEI number
- 3026478941
- DUNS number
- 118961679
- EUDAMED status
- Active
- EUDAMED registered name
- StaClear, Inc.
- Registered address
- 7250, ACC Boulevard, 27617, RALEIGH, United States
- Website
- www.staclear.com
- [email protected]
- Phone
- +1 919 838 6716
- PRRC contact
- Jackson Thornton
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 1 Nov 2029
Intertek Medical Notified Body AB 2862 2 certificates
- 28620214480 Active
Quality management system EU MDR
- Issued
- 12 Jun 2025
- Expires
- 1 Nov 2029
- 28620214481 Active
Quality management system EU MDR
- Issued
- 12 Jun 2025
- Expires
- 1 Nov 2029
Frequently asked questions
How many devices does Staclear, Inc. have in the registry?
The registry currently lists 6 devices for Staclear, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Staclear, Inc.'s devices?
Among its 6 most recently registered devices, Staclear, Inc. has devices listed in EUDAMED (3 devices), FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Staclear, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Staclear, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Staclear, Inc.?
EUDAMED lists 2 certificates for Staclear, Inc. (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 12 Jun 2025.
What are the newest devices from Staclear, Inc. in the registry?
The most recently registered devices listed for Staclear, Inc. include StaClear SC250, StaClear SC250LS, StaClear SC250LL and StaClear SC250AN.