NewGel+ Silicone Gel Sheeting

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref NG-360Ref NG-380Ref NG-170Ref NG-101SRef NG-326Ref NG-301S2Ref NG-180Ref NG-363Ref NG-328Ref NG-301Ref NG-324Ref NG-301S1Ref NG-320Ref NG-900Ref NG-370

by Newmedical Technology, Inc.

Identity

Trade Name: NewGel+ EUDAMED
NewGel+ Silicone Gel Sheeting FDA UDI
Generic Name: Scar-management dressing, reusable FDA UDI
Device Name: NewGel+ Silicone Gel Sheeting EUDAMED
NG-363 NewGel+ Clear Silicone Abdomen Sheet, 2"x18" (5.1x45.7cm), 1 pc/package FDA UDI
NG-326 NewGel+ Clear Silicone Anchor, 10"x4 1/8" (25.4x10.5cm), 2 pcs/package FDA UDI
NG-370 NewGel+ Clear Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package FDA UDI
NG-301 NewGel+ Clear Silicone Sheet, 5"x6" (12.7x15.2cm), 1 pc/package FDA UDI
NG-324 NewGel+ Clear Silicone Lollypop, 2 7/8"x6 1/2" (7.2x16.4cm), 2 pcs/package FDA UDI
NG-180 NewGel+ Beige Silicone Dots, 1" dia. (2.5cm dia.), 6 pcs/package FDA UDI
NG-170 NewGel+ Beige Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package FDA UDI
NG-301S2 NewGel+ Clear Silicone Strips, 1"x6" (2.5x15.2cm), 2 pcs/package FDA UDI
NG-328 NewGel+ Clear Silicone Breast Kit, 2 pcs Areola & 2 pcs Anchor/package FDA UDI
NG-380 NewGel+ Clear Silicone Dots, 1" dia. (2.5cm dia.), 6 pcs/package FDA UDI
NG-320 NewGel+ Clear Silicone Areola, 2 7/8" dia. (7.2cm dia.), 2 pcs/package FDA UDI
NG-101S NewGel+ Beige Silicone Strips, 1"x6" (2.5x15.2cm), 4 pcs/package FDA UDI
NG-900 NewGel+ Silicone Belly Button, 0.54" dia. (1.4cm dia.), 1 pc/package FDA UDI
NG-360 NewGel+ Clear Silicone Abdomen Sheet, 2"x8" (5.1 x20.3tm), 2 pcs/package FDA UDI
NG-301S1 NewGel+ Clear Silicone Strip, 1"x6" (2.5x15.2cm), 1 pc/package FDA UDI
Model / Reference: NG-363 EUDAMEDFDA UDI
NG-326 EUDAMEDFDA UDI
NG-370 EUDAMEDFDA UDI
NG-301 EUDAMEDFDA UDI
NG-324 EUDAMEDFDA UDI
NG-180 EUDAMEDFDA UDI
NG-170 EUDAMEDFDA UDI
NG-301S2 EUDAMEDFDA UDI
NG-328 EUDAMEDFDA UDI
NG-380 EUDAMEDFDA UDI
NG-320 EUDAMEDFDA UDI
NG-101S EUDAMEDFDA UDI
NG-900 EUDAMEDFDA UDI
NG-360 EUDAMEDFDA UDI
NG-301S1 EUDAMEDFDA UDI
Description: NG-363 NewGel+ Clear Silicone Abdomen Sheet, 2"x18" (5.1x45.7cm), 1 pc/package FDA UDI
NG-326 NewGel+ Clear Silicone Anchor, 10"x4 1/8" (25.4x10.5cm), 2 pcs/package FDA UDI
NG-370 NewGel+ Clear Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package FDA UDI
NG-301 NewGel+ Clear Silicone Sheet, 5"x6" (12.7x15.2cm), 1 pc/package FDA UDI
NG-324 NewGel+ Clear Silicone Lollypop, 2 7/8"x6 1/2" (7.2x16.4cm), 2 pcs/package FDA UDI
NG-180 NewGel+ Beige Silicone Dots, 1" dia. (2.5cm dia.), 6 pcs/package FDA UDI
NG-170 NewGel+ Beige Silicone Blanket, 10"x24" (25.4x61.0cm), 1 pc/package FDA UDI
NG-301S2 NewGel+ Clear Silicone Strips, 1"x6" (2.5x15.2cm), 2 pcs/package FDA UDI
NG-328 NewGel+ Clear Silicone Breast Kit, 2 pcs Areola & 2 pcs Anchor/package FDA UDI
NG-380 NewGel+ Clear Silicone Dots, 1" dia. (2.5cm dia.), 6 pcs/package FDA UDI
NG-320 NewGel+ Clear Silicone Areola, 2 7/8" dia. (7.2cm dia.), 2 pcs/package FDA UDI
NG-101S NewGel+ Beige Silicone Strips, 1"x6" (2.5x15.2cm), 4 pcs/package FDA UDI
NG-900 NewGel+ Silicone Belly Button, 0.54" dia. (1.4cm dia.), 1 pc/package FDA UDI
NG-360 NewGel+ Clear Silicone Abdomen Sheet, 2"x8" (5.1 x20.3tm), 2 pcs/package FDA UDI
NG-301S1 NewGel+ Clear Silicone Strip, 1"x6" (2.5x15.2cm), 1 pc/package FDA UDI

Identifiers

Primary DI / UDI-DI: 00816465021005 EUDAMEDFDA UDI
00816465020930 EUDAMEDFDA UDI
00816465021043 EUDAMEDFDA UDI
00816465020329 EUDAMEDFDA UDI
00816465020916 EUDAMEDFDA UDI
00816465021050 EUDAMEDFDA UDI
00816465021036 EUDAMEDFDA UDI
00816465020855 EUDAMEDFDA UDI
00816465020954 EUDAMEDFDA UDI
00816465020343 EUDAMEDFDA UDI
00816465020350 EUDAMEDFDA UDI
00816465020886 EUDAMEDFDA UDI
00816465021067 EUDAMEDFDA UDI
00816465020985 EUDAMEDFDA UDI
00816465020848 EUDAMEDFDA UDI
Basic UDI-DI: 081646502NGSG3 EUDAMED
510(k) Number: K041704 FDA UDI
FDA Product Code: MDA FDA UDI
EMDN Code: M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
GMDN Term: Scar-management dressing, reusable FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 878.4025 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Scar-management dressing, reusable

NewGel+ Silicone Gel Sheeting by Newmedical Technology, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Scar-management dressing, reusable.

MEDLOT — Henan Maidingkang Medical Technology Co., Ltd. · Class I
Blister plaster — Shenzhen Huashengyuan Technology Co., Ltd · Class I
Transeal Triple Release — DEROYAL INDUSTRIES, INC. · Class I
URGO Ongles abimés, par mycoses et traumatismes légers — Laboratoires URGO HEALTHCARE · Class I
Wound Plaster — Jinhua Jingdi Medical Supplies Co.,Ltd. · Class I
Oleeva Fabric 2x8 — BIO MED SCIENCES, INC. · Class I
Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc. · Class I
THERAFOAM — BIODERMIS LLC · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Newmedical Technology, Inc.

Sources (30)

FDA UDI c4fa8b5c-7219-466e-8bc0-248f25f48e66 36 fields · synced Sep 30, 2026
FDA UDI 627fd2dd-3103-4f81-ac69-147809ceef51 36 fields · synced May 29, 2026
FDA UDI d16bea96-268c-4575-a830-7d7c6622a43e 36 fields · synced May 29, 2026
FDA UDI 8ed806b5-8bac-499c-a632-9041a5b82208 36 fields · synced May 30, 2026
FDA UDI 53292b14-f560-4a49-8c1d-4fd068c003f5 36 fields · synced May 30, 2026
FDA UDI 751481ad-943e-4334-9af9-6c9482722254 36 fields · synced May 30, 2026
FDA UDI b0cf548e-77dd-4086-a6fb-c40281f8513a 36 fields · synced May 30, 2026
FDA UDI f59b59b7-3a30-4df9-9e8d-b761e43946e5 36 fields · synced May 30, 2026
FDA UDI 374a668d-027f-44ad-a3a2-570b520829b0 36 fields · synced May 30, 2026
FDA UDI 1a707aab-547e-4b41-a770-345f64acbff1 36 fields · synced May 30, 2026
FDA UDI c89de669-e898-4672-b114-605dbc1dee85 35 fields · synced May 30, 2026
FDA UDI 87926a7d-deea-4d50-b319-7f4a97193b39 36 fields · synced May 30, 2026
FDA UDI 644ee57b-a9ff-4327-a7ab-d5f82d3f2b6d 36 fields · synced May 30, 2026
FDA UDI 2c76c1ff-47b2-4c5a-b059-b4424a370b46 36 fields · synced May 30, 2026
FDA UDI 0cd0ff71-cd13-4d41-8970-ef1c1d0b8258 36 fields · synced May 30, 2026
EUDAMED 0303d2d2-562b-47dc-a5a3-1c9b5e61a345 61 fields · synced Jun 20, 2026
EUDAMED b4e60087-becf-4f44-844d-267aa71cb9b0 61 fields · synced Jun 20, 2026
EUDAMED caf4edea-5cfc-499f-8591-2728969fe738 61 fields · synced Jul 9, 2026
EUDAMED 37b557fd-94cd-4017-a3af-74d049b1aede 61 fields · synced Jul 10, 2026
EUDAMED e9ca0a58-bd55-4610-8d9e-f9f89049bf56 61 fields · synced Jul 12, 2026
EUDAMED 65fdd5d5-e561-446a-828d-8185007927b4 61 fields · synced Jul 14, 2026
EUDAMED 63b8490d-d63b-46e2-b910-ce3c8d02d171 61 fields · synced Jul 19, 2026
EUDAMED 34ac0e88-88a5-4a19-b845-62287c549935 61 fields · synced Jul 19, 2026
EUDAMED 6783f234-fb0b-4f13-9342-e47c7cd16022 61 fields · synced Jul 26, 2026
EUDAMED c596a56f-6906-4257-8be5-3d4f0612a737 61 fields · synced Jul 26, 2026
EUDAMED d29a207c-17aa-40d8-9c07-7707999ee8e7 61 fields · synced Jul 29, 2026
EUDAMED a4138208-d788-4526-b35b-ceebd170feaf 61 fields · synced Jul 31, 2026
EUDAMED 699c8290-b665-4607-95f3-c38c2a65f372 61 fields · synced Aug 2, 2026
EUDAMED 6ee0987e-0230-43af-98c4-c20201a49837 61 fields · synced Aug 3, 2026
EUDAMED fa7ba2cd-e350-4a6e-abfb-32df07a791f1 61 fields · synced Sep 30, 2026

NewGel+ Silicone Gel Sheeting

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (30)