FDA Registration
Active
🇬🇧 United Kingdom
FIRST WATER RAMSBURY LTD
Reg #: 9680731
·
FEI: 3002265219
·
Expires 2026
Products
6
Proprietary Names
180
Establishment Types
3
Classifications
6
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Registration Details
- Registration Name
- FIRST WATER RAMSBURY LTD
- Registration Number
- 9680731
- FEI Number
- 3002265219
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hilldrop Lane, Ramsbury
- City
- Marlborough Wiltshire
- Country
- GB
Owner / Operator
- Firm Name
- GENTELL
- Operator Number
- 10026501
- Address
- 180 Rittenhouse Circle
- City
- Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
US Agent
- Business Name
- Gentell
- Contact Name
- Michael Alford
- Address
- 1000 Floral Vale Blvd Ste 400
- City
- Yardley
- State
- PA
- ZIP
- 19067
- Country
- US
- [email protected]
- Phone
- 800 8409041
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-09-11 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2008-09-02 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2024-09-13 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2008-09-02 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2026-03-17 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2008-09-02 |
Proprietary Names
DE2LS/651/C1/1 - L-Mesitran Gentell Hydro 12cm x 8.5cm
DE3LS/651/C1/1 - L-Mesitran Gentell Hydro 18cm x 12.5cm
D3LS/651/C1/4 - L-Mesitran Hydro 10cm x 10cm
D3LB/651/C1/4 - L-Mesitran Border 10cm x 10cm
P3LB/651/C1/3 - Theraskin Active Large
DE1LS/651/C1/1 - L-Mesitran Gentell Hydro 6cm x 6cm
HC1515 Hydro Fiber Dressing 15x15cm / 6x6in
GEN-15480 Bordered Gauze 4" x 8"
GEN-19690 Sacral Silicone Superabsorbent Dressing
DUP86266-9 - Xtrasorb Foam Adhesive
DUP86144-9 - Xtrasorb Foam Non-Adhesive
GEN-14700 Gentell Bordered Silicone Foam Sacral ; 9 x 9
GEN-14544 Gentell Waterproof Foam Dressing(Non-Bordered);4"x 4"
DUP89533 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 3" X 3"
DUP86144 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 4" X 4.75"
GEN-14540 Gentell Split Drain Foam Dressing(Non-Bordered);4 x 5
GEN-15440 Gentell Split Drain Bordered Gauze; 4"
GEN-14410 Gentell Circular Split Drain Foam Dressing; 4"
GEN-15410 Gentell Bordered Gauze; 4" x 4''
GEN-13480 Gentell Calcium Alginate Dressing; 4" x 8"
GEN-19420 Gentell Super Absorbent Adherent Dressing; 2" x 2"
DUP86244 Xtrasorb Super Absorbent Dressing Foam Adhesive 4.5" X 4.5"
GEN-13200 Gentell Calcium Alginate Dressing; 2" x 2"
GEN-19640 Gentell Silicone Super Absorbent Dressing; 4"x4"
GEN-19340 Gentell Super Absobent Dressing; 4"x 4"
GEN-14400 Gentell Bordered Foam; 4" x 4"
DUP89569 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 6" X 9"
DUP88112 Algicell Calcium Alginate Dressing 3/4" x 12"
GEN-19460 Gentell Superabsorbent Adherent Dressing 6" x 6"
DUP86244-9 - Xtrasorb Foam Adhesive
GEN-13040 Gentell CMC Fiber Dressing; 4" x 4"
DUP86266 Xtrasorb Super Absorbent Dressing Foam Adhesive 6" X 6"
DUP86188-9 - Xtrasorb Foam Non-Adhesive
DUP88022 Algicell Calcium Alginate Dressing 2" x 2"
DUP86233-9 - Xtrasorb Foam Adhesive
DUP88100 Algicell Calcium Alginate Dressing 3/4" X 36"
CFT2020 Polyurethane Foam Tracheostomy Dressing 20x20cm / 8x8in
GEN-15610 Gentell Bordered Gauze; 6" x 6"
GEN-15414 Gentell Silicone Bordered Gauze; 4"x4"
GEN-14744 Gentell Bordered Silicone Foam; 4"x 4"
GEN-19680 Gentell Silicone Super Absorbent Dressing; 8"x8"
DUP86122 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 2" X 2"
GEN13060 Gelling Fiber Dressing 6x6 (15cmx15cm)
DUP86388 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 8" X 8"
GEN13020 Gelling Fiber Dressing 2x2 (5cmx5cm)
GEN-14522 Gentell Waterproof Foam Dressing(Non-Bordered);2"x 2"
A 0505 Calcium Alginate Dressing 5x5cm / 2x2in
HC0505 Hydro Fiber Dressing 5x5cm / 2x2in
GEN-19320 Gentell Super Absobent Dressing; 2"x 2"
GEN-19350 Gentell Super Absobent Dressing; 5"x 5"
CFT1010 Polyurethane Foam Tracheostomy Dressing 10x10cm / 4x4in
GEN-13120 Gentell Calcium Alginate Dressing; 12" Rope
CF1010 Polyurethane Foam Dressing 10x10cm / 4x4in
DUP88048 Algicell Calcium Alginate Dressing 4" x 8"
GEN-12400 Comfortell Composite Dressing; 4" x 4"
GEN-11260 Gentell Acute Surgical Incisions Dressing
DUP86433 Xtrasorb Super Absorbent Dressing HCS Adhesive 3" X 3"
GEN-13020 Gentell CMC Fiber Dressing; 2" x 2"
GEN-14766 Gentell Bordered Silicone Foam; 6"x 6"
DUP86233 Xtrasorb Super Absorbent Dressing Foam Adhesive 3.2" X 3.2"
GEN-19480 Gentell Super Absorbent Adherent Dressing; 8" x 8"
GEN-13010 Gentell Calcium Alginate Dressing; 10" x 10"
DUP86344 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 4.5" X 4.5"
DUP88044 Algicell Calcium Alginate Dressing 4" x 4"
GEN-14600 Gentell Bordered Foam; 6" x 6"
GEN-14777 Gentell Bordered Silicone Foam; 7"x 7"
GEN-13500 Gentell Calcium Alginate Dressing; 4" x 4"
GEN-13700 Gentell Calcium Alginate Dressing; 6" x 6"
61-89545 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 5"
DUP86322 Xtrasorb Super Absorbent Dressing HCS Non Adhesive 2.3" X 2.3"
GEN-12600 Comfortell Composite Dressing; 6" x 6"
GEN-19380 Gentell Super Absobent Dressing; 8"x 8"
DUP86188 Xtrasorb Super Absorbent Dressing Foam Non-Adhesive 8" X 8"
GEN13040 Gelling Fiber Dressing 4x4 (10cmx10cm)
Lansinoh C section Hydrogel Pads
DUP86122-9 - Xtrasorb Foam Non-Adhesive
GEN-13060 Gentell CMC Fiber Dressing; 6" x 6"
A 1010 Calcium Alginate Dressing 10x10cm / 4x4in
GEN-19450 Gentell Super Absorbent Adherent Dressing; 5" x 5"
GEN-14799 Gentell Bordered Silicone Foam; 9"x 9"
DUP89545 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 5"
DUP86466 Xtrasorb Super Absorbent Dressing HCS Adhesive 6" X 6"
GEN-15616 Gentell Silicone Bordered Gauze; 6"x6"
GEN-14588 Gentell Waterproof Foam Dressing(Non-Bordered); 8"x 8"
GEN-14555 Gentell Waterproof Foam Dressing(Non-Bordered); 5"x 5"
GEN-15810 Gentell Bordered Gauze; 8" x 8"
GEN-15818 Gentell Silicone Bordered Gauze; 8"x8"
GEN-19660 Gentell Silicone Super Absorbent Dressing; 6"x6"
DUP89544 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 4" X 4"
A 1020 Calcium Alginate Dressing 10x20cm / 4x8in
CF060607 Polyurethane Foam Dressing 6x6cm / 3x3in
61-89569 Xtrasorb Super Absorbent Dressing Classic Non- Adhesive 6" X 9"
HC1010 Hydro Fiber Dressing 10x10cm / 4x4in
A 0230 Calcium Alginate Dressing 2x30cm / .8x12in
MM0121 Gentell Fiber Dressing 5 x 5 (10cm x 12.5cm) (formerly MEDSAF 5 x 5 (10cm x 12.5cm))
A 1515 Calcium Alginate Dressing 15x15cm / 6x6in
CF2020 Polyurethane Foam Dressing 20x20cm / 8x8in
F12LB/648/C1/2 Dr Scholl's Blister Cushion Dressing
F10LB/599/G2/2 Dr Scholls Corn Cushion - New Liner
GEN-11130 Gentell Hydrogel Wound Dressing 3oz / 85g
73231-02 - Cutimed Hydrocontrol
Curad Soothe & Cool Dressing (74 x 45mm)
ZGIH44 HYDROGEL IMPREGNATED GAUZE DRESSING 4"X 4" Reliamed
6030-4157 - Glaciergel
61-53022 HYDROGEL IMPREGNATED GAUZE DRESSING 2"X 2" MCKESSON
DUP81110 Aquasite Amorphous Hydrogel Dressings 1 fl oz Bellows
G025 Amorphous Hydrogel with Alginate 1oz/25g
Curad Soothe & Cool Dressing (56 x 26mm)
GEN-11700 Gentell Hydrogel Sheet Dressing Borderless 7 x 5 (17.8cm x 12.7cm)
DUP53044 Aquasite Impregnated Gauze Size 4" x 4"
CWL 1004 - KerraLite Cool
6030-4156 - Glaciergel
CWL 1008 - KerraLite Cool Border
73231-00 - Cutimed Hydrocontrol
CBL-1212-118 12"X12" FOAM DRESSING
BSN7261002- Cutimed Hydrogel 25 grams tube w/applicator
53022 Aquasite Impregnated Gauze Size 2" x 2"
Medela Breast Pads (USA)
CVS86433-9 Xtrasorb HCS Non-Adhesive 3"x3" (cvs)
73230-03 - Leukomed Control
BSN7261001- Cutimed Hydrogel 15 grams tube w/applicator
DUP86388-9 - Xtrasorb HCS Non-Adhesive
DUP86433-9 - Xtrasorb HCS Non-Adhesive
53048 Aquasite Impregnated Gauze Size 4" x 8"
81110 HYDROGEL WOUND DRESSING 1 FL.OZ. MCKESSON
Russell Chest Seal
CWL 1009 - KerraLite Cool Border
73230-01 - Leukomed Control
G085 Amorphous Hydrogel with Alginate 3oz/85g
CWL 1007 - KerraLite Cool Border
CWL 1005 - KerraLite Cool
DH-03 Dermagran Hydrogel Wound Dressing 3oz
DUP81122 Aquasite Hydrogel Impregnated Non-Woven Dressing 2" x 2"
GEN-11470 Gentell Hydrogel Sheet Dressing Borderless 4.7 x 3.4 (12cm x 8.6cm)
CBL-0206- 118 2"X 6" FOAM DRESSING
DUP81144 Aquasite Hydrogel Impregnated Non-Woven Dressing 2" x 2"
73231-01 - Cutimed Hydrocontrol
61-53044 HYDROGEL IMPREGNATED GAUZE DRESSING 4"X 4" MCKESSON
73230-02 - Leukomed Control
73230-05 - Leukomed Control
73230-00 - Leukomed Control
40-2979 - Hydrogel Dressing
DUP86344-9 Xtrasorb HCS 4.5"x4.5"
CVS53022-4 CVS MOIST COOLING BURN PAD 2" X 2"
GEN-11240 Gentell Hydrogel Sheet Dressing Borderless 2.4 x 2.4 (6cm x 6cm)
CWL 1006 - KerraLite Cool
73231-03 - Cutimed Hydrocontrol
DUP86466-9 - Xtrasorb HCS Adhesive
DUP86322-9 Xtrasorb HCS 2.3"x2.3"
DUP53048 Aquasite Impregnated Gauze Size 4" x 8"
CBL-0404 - 118 4"X 4" FOAM DRESSING
CBL-0808-118 8"X 8" FOAM DRESSING
BSN7261000- Cutimed Hydrogel 8 grams tube w/applicator
BSN7261003- Cutimed Hydrogel 15 grams tube
65045 Lansinoh Soothies Relief+ Cooling Gel Nipple Pads (6 pads)
NG25- NASO GASTRIC STRIP ADULT
DUP62039 Ultrafix Self-Adhesive Dressing Covering (8" x 10.9yds /20cm x 10m)
DUP62036 Ultrafix Self-Adhesive Dressing Covering (2" x 10.9yds /5cm x 10m)
P5LB/548/G2/2 Aquaheal Second Skin
NG40- NASO GASTRIC STRIP PEDIATRIC
CS50-CATH-STRIP CATHETER FASTENER
GEN-10640 Gentell FixTape 4" x 11yards
NG60- NASO GASTRIC STRIP INFANT
NG50- NASO GASTRIC STRIP ADULT
P3LB/548/G2/2 Aquaheal Second Skin
UC20- UC-STRIP CATHETER TUBING FASTENER
DA3XS/631/C1/2 V.A.C. Seal Hydrogel Strip
GEN-10600 Gentell FixTape 2" x 11yards
GEN-10625 Silicone Fixtape 2"x5 Yards
DUP62037 Ultrafix Self-Adhesive Dressing Covering (4" x 10.9yds /10cm x 10m)
DUP62038 Ultrafix Self-Adhesive Dressing Covering (6" x 10.9yds /15cm x 10m)
72646-03 - Cutimed Sorbact Hydroactive ST
72646-04 - Cutimed Sorbact Hydroactive ST
72646-05 - Cutimed Sorbact Hydroactive ST
79933-02 - Cutimed Sorbact Hydroactive Border ST
79933-00 - Cutimed Sorbact Hydroactive Border ST
72646-07 - Cutimed Sorbact Hydroactive ST
72646-06 - Cutimed Sorbact Hydroactive ST
79933-03 - Cutimed Sorbact Hydroactive Border ST
79933-04 - Cutimed Sorbact Hydroactive Border ST
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198