FDA Registration
Active
🇨🇳 China
Jiangsu Guangda Medical Material Group Co., Ltd.
Reg #: 3006847952
·
FEI: 3006847952
·
Expires 2026
Products
32
Proprietary Names
21
Establishment Types
4
Classifications
32
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Registration Details
- Registration Name
- Jiangsu Guangda Medical Material Group Co., Ltd.
- Registration Number
- 3006847952
- FEI Number
- 3006847952
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18 Baochang Road North
- City
- Haian Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201718
Owner / Operator
- Firm Name
- Jiangsu Guangda Medical Material Group Co., Ltd.
- Operator Number
- 10023676
- Address
- 18 Baochang Road North
- City
- Haian
- State
- Jiangsu
- Postal Code
- 226631
- Country
- CN
- Correspondent
- Guo Rong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-04-17 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-03 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2007-12-07 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2013-03-19 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2008-11-24 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2022-10-14 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2008-11-25 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2008-11-24 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2013-12-30 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2008-11-24 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2007-12-07 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2007-12-07 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2007-12-07 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2008-11-24 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2007-12-07 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2013-03-19 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2008-11-24 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2008-11-24 |
| Stabilizer, Heart | MWS | Class 1 | Cardiovascular | No | 2015-04-10 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2017-05-19 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2007-12-07 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2007-12-07 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2008-11-24 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2007-12-07 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2013-03-19 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2008-11-24 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-05-01 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2008-11-24 |
| Parenteral Administration Kit | POR | Class 2 | General Hospital | No | 2025-08-04 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2020-05-04 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2019-06-18 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2008-11-24 |
Proprietary Names
MASK, SURGICAL
Drape, Surgical, Exempt
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Tongue Depressors
Towel
Medical Disposal Protective Clothing
DRAPE, SURGICAL
Ice Bag
BANDAGE, ELASTIC
Cotton Ball; Cotton Roll
Wood Applicator
Stabilizer, Heart
Cover
Face mask
Coverall
Cotton Tipped Applicators, Sterile
Face Mask
Insulin Injection Kit
Gown, Surgical
Device, Occlusion, Umbilical
baby blanket; stretcher sheets
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility