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Revanesse UltraRevanesse Versa

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Revanesse Ultra is a Skin booster product (Class III device), registered by Prollenium Medical Technologies Inc.. Linked registrations: EU B-PN40004PK, EU B-PN40011PG, EU B-PN40102PL and 5 more. First approved in US on 2017-08-04 (P160042). Data as of 2026-11-09.

  • Regulatory classSkin booster · Class III device
  • HolderProllenium Medical Technologies Inc.
  • JurisdictionsUS · EU · UK · AU
  • Updated2026-11-09 · v1

Registration and basics are public; findings and prices need an account

Registration and basics

Revanesse Ultra

Product
Regulatory class
Class III device
Category
Skin booster
EU · EUDAMED device record
B-PN40004PK
EU · EUDAMED device record
B-PN40011PG
EU · EUDAMED device record
B-PN40102PL
EU · EUDAMED device record
B-PN40103PN
UK · MHRA device registration (not an approval)
PARD-3283624
UK · MHRA device registration (not an approval)
PARD-2146004
UK · MHRA device registration (not an approval)
PARD-2146012
UK · MHRA device registration (not an approval)
PARD-2146029
Other registrations
2 more, see the timeline
Name on registration
Revanesse® Ultra 1.0 mL
Registrant
Prollenium Medical Technologies Inc.
EU authorised representative
Emergo Europe B.V.（NL-AR-000000116）
First approval
Not obtained from an official source
Checked against official page
Not yet checked field by field against the live official page

Public: fields from the registration record.Registrant and dates are from B-PN40004PK; 10 registrations linked.

Label facts by jurisdiction

What each jurisdiction's label says for the same attribute; gaps are marked Not reported, irrelevant ones N/A

No data yet

Registration timeline

  1. US

    P160042 first approved

  2. UK

    PARD-2146004 registered

  3. UK

    PARD-2146012 registered

  4. UK

    PARD-2146029 registered

  5. UK

    PARD-3283624 registered

  6. AU

    450106 ARTG start date

  7. US

    P160042 · P160042/S016

    Normal 180 Day Track｜Change Design/Components/Specifications/Material｜Approval for the qualification of hyaluronic acid (HA) from a new supp…

  8. US

    P160042 · P160042/S026

    Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/tradename｜Approval for standardizing the descriptive informa…

  9. US

    P160042 · P160042/S024

    135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval for the addition of a mixer discharge…

  10. US

    P160042 · P160042/S029

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approval for modifications to cleanroom layout in a secondary manuf…

  11. US

    P160042 · P160042/S031

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜new polyvinyl chloride material used in secondary packaging for Rev…

  12. US

    P160042 · P160042/S032

    30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approval to qualify a Third-Party Logistics (3PL) supplier for ware…

First approval, this certificate's issue date (updated after renewals or changes), changes and expiry are listed separately; a missing first approval means it was not obtained from an official source. Up to 6 recent changes per registration; click the number for the full record. Dates on non-Chinese registrations keep the source's wording: UK devices show the registration date (MHRA does not approve them), Australia the ARTG start date, FDA devices the decision date.

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Recent changes

5
  • P160042: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜Approva…2026-10-14
  • P160042: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜new pol…2026-05-08
  • P160042: 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Packager/Supplier｜approva…2025-12-22
  • P160042: 135 Review Track For 30-Day Notice｜Process Change - Manufacturer/Sterilizer/Pack…2024-08-20
  • P160042: Special (Immediate Track)｜Labeling Change - Indications/instructions/shelf life/…2024-07-12

Sources

10