Emboline, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000045772 FEI 3044466298
- Devices
- 3
- 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
Catalogue
Emboline Angiographic Catheter Ref EPT-01
Regimes: CE MDR Registry: EUDAMED- Registry: GUDID
Emboliner Embolic Protection System (EPC-03) Ref K261715
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- US-MF-000045772
- FDA FEI number
- 3044466298
- DUNS number
- 056234950
- EUDAMED status
- Active
- EUDAMED registered name
- Emboline, Inc.
- EUDAMED abbreviated name
- Emboline
- Registered address
- 2901, Mission St., 95060, Santa Cruz, United States
- Website
- emboline.com
- [email protected]
- Phone
- +31889951333
- PRRC contact
- Will Michul
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 18 Aug 2031
BSI Group The Netherlands B.V. 2797 2 certificates
- MDR 821553 Active
Quality management system EU MDR
- Issued
- 19 Aug 2026
- Expires
- 18 Aug 2031
- MDR 823385 Active
Technical documentation EU MDR
- Issued
- 19 Aug 2026
- Expires
- 18 Aug 2031
From the company website
The Emboliner® is a total-body embolic protection system designed to capture debris during transcatheter procedures, helping reduce stroke and ischemic complications.
Frequently asked questions
How many devices does Emboline, Inc. have in the registry?
The registry currently lists 3 devices for Emboline, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Emboline, Inc.'s devices?
Among its 3 most recently registered devices, Emboline, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Emboline, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Emboline, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Emboline, Inc.?
EUDAMED lists 2 certificates for Emboline, Inc. (quality management system; technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 19 Aug 2026.
What are the newest devices from Emboline, Inc. in the registry?
The most recently registered devices listed for Emboline, Inc. include Emboline Angiographic Catheter, Emboliner Embolic Protection System EPC-03 and Emboliner Embolic Protection System (EPC-03).