GENTELL
Registration 2530957FEI 1000522686Bristol, PA
Owner/operator: GENTELL
- Repack or Relabel Medical Device
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
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 22
- Added, last 12 months
- 3
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 22
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| EZS | OR1000 Ostomy Ring 2" StandardAppliance, Colostomy, Disposable | Class 1 | 21 CFR 876.5900 | — |
| EXH | 3245-00C Drainable pouch 1piece adhesive clear 13/64mmBag, Urinary, Ileostomy | Class 1 | 21 CFR 876.5900 | — |
| EXG | 5145-00C Urostomy Pouch adhevise 1 piece clearBag, Urine Collecting, Ureterostomy | Class 1 | 21 CFR 876.5900 | — |
| FQM | BulkNetBandage, Elastic | Class 1 | 21 CFR 880.5075 | — |
| EZR | 330G Ostomy Elastic Belt largeCement, Stomal Appliance, Ostomy | Class 1 | 21 CFR 876.5900 | — |
| EXB | 530 Ostomy Lubricant Deodorant 100ml 3.4ozCollector, Ostomy | Class 1 | 21 CFR 876.5900 | — |
| NAE | 40-2979 - Hydrogel DressingDressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | 21 CFR 878.4022 | — |
| NAC | 61-89545 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 5"Dressing, Wound, Hydrophilic | Class 1 | 21 CFR 878.4018 | — |
| NAD | 61-77041 Oil Emulsion Dressing 3"X3"Dressing, Wound, Occlusive | Class 1 | 21 CFR 878.4020 | — |
| NAB | DUP9322- Gazetex gauze bandage roll 4.5 in X 4.1 yardsGauze / Sponge,Nonresorbable For External Use | Class 1 | 21 CFR 878.4014 | — |
| EZQ | 2245-00C Closed-end pouch adhesive 1 piece clear 13/64mmPouch, Colostomy | Class 1 | 21 CFR 876.5900 | — |
| EXE | 7000 Ostomy Hydrocolloid StripsProtector, Ostomy | Class 1 | 21 CFR 876.5900 | — |
and 10 more on your full dossier
What changed
- Mar 20, 2026Listing added: FRO — MM0048 Gentell Manuka Honey Wound Dressing 20g (formerly MANUKApli 20g) (K092689)
- Mar 20, 2026Listing added: FRO — MM0010 Gentell Manuka Honey Non-Adherent Dressing 4 x 5 (10 x 12.5cm) (formerly MANUKAtex 4 x 5 (10 x 12.5cm)) (K110042)
- Mar 20, 2026Listing added: FRO — MM0013 Gentell Manuka Honey Fiber Premium 2 x 2 (5 x5cm) (formerly MANUKAhd 2 x 2 (5 x5cm)) (K102659)