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sayphasaypha filler (Lidocaine)

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saypha is a Hyaluronic acid filler product (Class III device), registered by CROMA GmbH. Linked registrations: EU 9003502PIMDFILIDO001VT, UK PARD-6353350, Australia 475369 and 2 more. First approved in US on 2026-06-12 (P250021). Data as of 2026-11-09.

  • Regulatory classHyaluronic acid filler · Class III device
  • HolderCROMA GmbH
  • JurisdictionsUS · EU · UK · AU
  • Updated2026-11-09 · v1

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

Registration and basics

saypha

Product
Regulatory class
Class III device
Category
Hyaluronic acid filler
EU · EUDAMED device record
9003502PIMDFILIDO001VT
UK · MHRA device registration (not an approval)
PARD-6353350
Australia · TGA ARTG device
475369
US · FDA PMA
P250021 (link pending review)
US · FDA PMA
P240008 (link pending review)
Name on registration
Aesthetic dermal filler - pack
Registrant
CROMA-PHARMA GmbH
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 9003502PIMDFILIDO001VT; 5 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. AU

    475369 ARTG start date

  2. US

    P240008 first approved

  3. US

    P250021 first approved

  4. UK

    PARD-6353350 registered

  5. US

    P250021 · P250021/S001

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval of the scale validation protocol for the post-approval study (PAS) ref…

  6. US

    P250021 · P250021/S002

    Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval of the protocol for the post-approval study (PAS) referenced above. Th…

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

3
  • P250021: Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval of the pro…2026-10-08
  • PARD-6353350: registered2026-10-07
  • P250021: Normal 180 Day Track No User Fee｜Postapproval Study Protocol｜Approval of the sca…2026-10-07

Sources

5