Guangzhou NEW Design Biotechnology Co., Ltd.
Registered establishment in Guangzhou, Guangdong, China. 11 device types.
Guangzhou NEW Design Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Orthosis, Lumbar, Orthosis, Cervical and 9 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | GUANGZHOU NEW DESIGN BIOTECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017910381 |
| FEI number | 3017910381 |
| Establishment type | Manufacturer |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Office 2001-6, No.353 Yijing Road, Haizhu District |
| Postal code | 510220 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | TE301A | 2023 | 118 |
| Foot Wrap For Treating Restless Leg Syndrome Symptoms | Class 1 | TL042A | 2024 | 5 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | PX4M | 2021 | 45 |
| Irrigator, Powered Nasal | Class 1 | KF003A,KF004A,WM133AF,DH153AF, TF201A, TL321AF | 2021 | 63 |
| Massager, Therapeutic, Electric | Class 1 | CI191A, DH153AD, LV021R, CI162AR, CI168AR, CI157AG, CI157AB,CI170A, CSG003, WD1, DH047A, WD3H, ED3, BD1 | 2020 | 437 |
| Massager, Therapeutic, Manual | Class 1 | DH013ASH, CI3201AF | 2021 | 113 |
| Orthosis, Cervical | Class 1 | JT1, JT2, JT3, JT4, JB1, JB2, JX1, JX2, JX3, LK020C,LK020D,LV2101A,LV2101B,LV2102A,LV2102B,LV2103A,LV2103B,LV2104A,LV2104B,LV2105A,LV2105B,K022A,, CI093, LK023A, LK020B, LK020A, LK026A, LK028A, LK022A, BA-JQ-C, | 2021 | 114 |
| Orthosis, Cervical-Thoracic, Rigid | Class 1 | LK020A,LK020B,LK020C,LK020D,LV2101A,LV2101B,LV2102A,LV2102B,LV2103A,LV2103B,LV2104A,LV2104B,LV2105A,LV2105B,TL031B,CI093 | 2022 | 30 |
| Orthosis, Corrective Shoe | Class 1 | MX1, MX2, MB1, MB2, MB3, MB4, MB5, MX3QB, MXHQB, MX3Q, MXH, MB1Q, TL046A, TL047A, MF2a, MF2b, MXHQY, MB6, MF5A, XHQB,, TE001A,TJ-608,TL142A,TE-X3,TE-F4,TC318A, TC-X3,TF-F2,TE-F3,TL318A,TL043A,TL041A,, X3QB, MB1H, MX3H, TL042A, GX1, P10 | 2021 | 51 |
| Orthosis, Lumbar | Class 1 | TL031B | 2022 | 110 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | TJ-608,TL142A, TL042A, WB1, WB2, WB3, WX1, WX2, WX3, WY1, WY2, ZX1, ZY1, ZY2, ZY3 | 2022 | 62 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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