MEDINOVA GROUP CO.
Registration 3044466317FEI 3044466317Laguna Beach, CA
Owner/operator: Medinova Group Co.
- Complaint File Establishment per 21 CFR 820.198
- Manufacture Device in the United States for Export Only
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 34
- Added, last 12 months
- 21
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 34
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| MMK | Container, SharpsGeneral Hospital | Class 2 | 21 CFR 880.5570 | K180984 |
| DJG | Enzyme Immunoassay, OpiatesClinical ToxicologyAdded May 9, 2026 | Class 2 | 21 CFR 862.3650 | — |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry | Class 2 | 21 CFR 862.1675 | K093910 |
| LYU | Accessory, Surgical ApparelGeneral, Plastic SurgeryAdded May 9, 2026 | Class 1 | 21 CFR 878.4040 | — |
| OMW | Adhesive Backed Thermal Skin PatchesPhysical MedicineAdded May 9, 2026 | Class 1 | 21 CFR 890.5710 | — |
| KXF | Applicator, Absorbent Tipped, Non-SterileGeneral HospitalAdded May 9, 2026 | Class 1 | 21 CFR 880.6025 | — |
| KXG | Applicator, Absorbent Tipped, SterileGeneral HospitalAdded May 9, 2026 | Class 1 | 21 CFR 880.6025 | — |
| ITG | Bandage, CastPhysical Medicine | Class 1 | 21 CFR 890.3025 | — |
| FQM | Bandage, ElasticGeneral Hospital | Class 1 | 21 CFR 880.5075 | — |
| KME | Bedding, Disposable, MedicalGeneral HospitalAdded May 9, 2026 | Class 1 | 21 CFR 880.6060 | — |
| NNK | Container, Specimen Mailer And Storage, Non-SterilePathologyAdded May 9, 2026 | Class 1 | 21 CFR 864.3250 | — |
| KDT | Container, Specimen Mailer And Storage, SterilePathology | Class 1 | 21 CFR 864.3250 | — |
and 22 more on your full dossier
What changed
- May 9, 2026Listing added: DJG — Enzyme Immunoassay, Opiates
- May 9, 2026Listing added: LYU — Accessory, Surgical Apparel
- May 9, 2026Listing added: OMW — Adhesive Backed Thermal Skin Patches
- May 9, 2026Listing added: KXF — Applicator, Absorbent Tipped, Non-Sterile
- May 9, 2026Listing added: KXG — Applicator, Absorbent Tipped, Sterile
- May 9, 2026Listing added: KME — Bedding, Disposable, Medical
- May 9, 2026Listing added: NNK — Container, Specimen Mailer And Storage, Non-Sterile
- May 9, 2026Listing added: JSG — Culture Media, Non-Selective And Non-Differential
- May 9, 2026Listing added: KIZ — Dish, Tissue Culture
- May 9, 2026Listing added: LRJ — Disinfectant, Medical Devices
- May 9, 2026Listing added: NAD — Dressing, Wound, Occlusive
- May 9, 2026Listing added: HTD — Forceps
- May 9, 2026Listing added: OEA — Non-Surgical Gown
- May 9, 2026Listing added: IMD — Pack, Hot Or Cold, Disposable
- May 9, 2026Listing added: HMP — Pad, Eye
- May 9, 2026Listing added: NNT — Punch, Gelfoam, Non-Sterile
- May 9, 2026Listing added: HOY — Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- May 9, 2026Listing added: KEW — Slides, Microscope
- May 9, 2026Listing added: FXO — Suit, Surgical
- May 9, 2026Listing added: KGX — Tape And Bandage, Adhesive
- May 9, 2026Listing added: FSM — Tray, Surgical, Instrument