Prollenium Medical Technologies Inc.
Active in EUDAMEDCanadafrom SRN EUDAMED FDA SRN CA-MF-000017924 FEI 3019585045
- Devices
- 36
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
Catalogue
Search and filter all 36 devicesCompany details
- EUDAMED SRN
- CA-MF-000017924
- FDA FEI number
- 3019585045
- EUDAMED status
- Active
- EUDAMED registered name
- Prollenium Medical Technologies Inc.
- EUDAMED abbreviated name
- PMT
- Registered address
- 138, Industrial Pkwy. N., L4G 4C3, Aurora, Canada
- [email protected]
- PRRC contact
- Denis Vezina
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 15 Nov 2018 Z-1146-2020 Class II Terminated Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Frequently asked questions
How many devices does Prollenium Medical Technologies Inc. have in the registry?
The registry currently lists 36 devices for Prollenium Medical Technologies Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prollenium Medical Technologies Inc.'s devices?
Among its 36 most recently registered devices, Prollenium Medical Technologies Inc. has devices listed in EUDAMED (35 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Prollenium Medical Technologies Inc.'s devices fall under?
Among its 36 most recently registered devices, the classes recorded for Prollenium Medical Technologies Inc.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Prollenium Medical Technologies Inc.?
FDA recall records list 1 recall initiated by Prollenium Medical Technologies Inc., the most recent initiated on 15 Nov 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Prollenium Medical Technologies Inc. in the registry?
The most recently registered devices listed for Prollenium Medical Technologies Inc. include Revanesse® Outline+ 1.0 mL, Revanesse Outline+ 1.2 mL, Revanesse Contour XL and Revanesse® Outline 1.2 mL.