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Device Explorer · FDA GUDID · GMDN 47887

Dermal tissue reconstructive material, microbe-derived, anaesthetic

A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix o

US‑registered devices153in commercial distribution
Companies16labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription84%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Q-Med Ab4731%
Allergan, Inc.2315%
Teoxane Sa1610%
Lambsmead Ltd149%
Univerderm96%
Nuvara Srl96%
Pharmamondis Gmbh75%
Symatese64%

Top labelers

CompanyDevicesShare
Q-Med Ab4731%
Allergan, Inc.2315%
Teoxane Sa1610%
Lambsmead Ltd149%
Univerderm96%
Nuvara Srl96%
Pharmamondis Gmbh75%
Symatese64%
Obagi Cosmeceuticals Llc43%
Prollenium Medical43%
Saima Global Farma S.L.43%
Merz North America, Inc.32%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

JuvedermRestylane ContourRestylane EyelightRestylane Lyft with LidocaineRestylane-LRestylane KysseRestylane DefyneRestylane RefyneRestylane Silk-LBelotero IntenseBelotero BalanceBelotero SoftRestylane Perlane + LidocaineRestylane 0.5 ML.+ LidocaineRestylane + LidocaineJuvederm Hydrate

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LMHImplant, Dermal, For Aesthetic Use183
PKYImplant, Dermal, For Aesthetic Use In The Hands1

GMDN & GCC registration

  • GMDN code 47887 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 84% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 20Total Volume (Milliliter) · 9

Use these as the dimensions to specify in a tender line.

How many dermal tissue reconstructive material, microbe-derived, anaesthetic products are registered in the US?

153 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dermal tissue reconstructive material, microbe-derived, anaesthetic", from 16 companies. The largest labeler is Q-Med Ab with 31% of records.

Which FDA product codes apply?

LMH (Implant, Dermal, For Aesthetic Use), PKY (Implant, Dermal, For Aesthetic Use In The Hands)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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