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Device Explorer · FDA GUDID · GMDN 61338

Eye dropper bottle

A sterile device intended to store and dispense in drops an eye irrigation solution typically to flush the eye of irritating particulates/chemicals, or to treat a specific eye condition. It does not contain eye irrigation solution. It consists of a small bottl

US‑registered devices201in commercial distribution
Companies3labelers on GUDID
Single‑use84%of device records
Sterile100%labelled sterile
Prescription39%Rx‑only share
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Share of device records

Mps Pharma & Medical, Inc.16884%
Medisca Inc.3216%
Mps Medical, Inc10%

Top labelers

CompanyDevicesShare
Mps Pharma & Medical, Inc.16884%
Medisca Inc.3216%
Mps Medical, Inc10%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dispenser, Liquid MedicationSAFEFILL™OptiDropper®OptiDropper®, SafeFill™DROPPER BOTTLE SYSTEMOptiDropper™TIPGUARD™ CAPS15-415 Series 7mL Dropper Bottle Natural, CylindDROPPER BOTTLE CAP SYSTEM15-415 Series 15mL Dropper Bottle Natural, CylinSAFEDATE™15-415 Series 15ml Dropper Bottle White, Boston 15-415 Series 15ml Dropper Bottle Natural, Bosto15-415 Series Natural Tip / Teal Cap Tray15-415 Series Natural Tip / Brown Cap Tray15-415 Series Natural Tip / Maroon Cap Tray

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

FDA product codes

CodeNameDevices
KYXDispenser, Liquid Medication232
KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 1

GMDN & GCC registration

  • GMDN code 61338 · non‑implantable
  • Single‑use 84% · sterile 100% · Rx‑only 39% · 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

No structured size data on the register.

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

How many eye dropper bottle products are registered in the US?

201 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Eye dropper bottle", from 3 companies. The largest labeler is Mps Pharma & Medical, Inc. with 84% of records.

Which FDA product codes apply?

KYX (Dispenser, Liquid Medication), KYK (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, )

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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