FDA Registration
Active
🇨🇳 China
SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD
Reg #: 3016426842
·
FEI: 3016426842
·
Expires 2026
Products
22
Proprietary Names
22
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD
- Registration Number
- 3016426842
- FEI Number
- 3016426842
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Tianfu Road, Dongcheng District, Shan County
- City
- Heze Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210518
Owner / Operator
- Firm Name
- SHANDONG HAIDIKE MEDICAL PRODUCTS Co., Ltd
- Operator Number
- 10061886
- Address
- Tianfu Road, Dongcheng District, Shan County
- City
- Heze
- State
- Shandong
- Postal Code
- 274300
- Country
- CN
- Correspondent
- Lili Xu
US Agent
- Business Name
- ICAS Biologics Co., Ltd.
- Contact Name
- Sarah Galemmo
- Address
- 20 Via Lucca D310
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 661 8033155
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-03-12 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2020-12-04 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-12 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-08-26 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-12-04 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2019-11-28 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2021-12-21 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-08-19 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2021-12-31 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-03-12 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2026-02-26 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2020-08-19 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2023-08-29 |
| Splint, Traction | HSP | Class 1 | Orthopedic | No | 2019-11-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2019-11-28 |
| 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 | 2020-04-11 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2024-06-27 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2023-09-21 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2024-01-19 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-03-12 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2019-11-28 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2019-11-28 |
Proprietary Names
Medical Cap
Sampling tube
Isolation Gown
Surgical Face Mask
Sampling swab
Medical cold compress
walking aid
Medical isolation mask
Non Absorbable Surgical Nylon Suture
Medical Goggle
Skin Staple Remover
Medical bed cover
Non-absorbable Surgical Polyester Suture
medical polymer splint
polymer fixed bandage
Disposable medical face mask
Disposable Skin Stapler
Non absorbable Surgical Polypropylene Suture
Non absorbable Surgical Silk Suture
Medical Isolation Shoe Cover
band-aid
elastic bandage
Establishment Types
Manufacture Medical Device