Shandong Haidike Medical Products Co., Ltd.
Manufacturer and brand owner in Heze, Shandong, China. 22 device types, 18 products catalogued, 3 clearances.
Shandong Haidike Medical Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Stapler, Skin and 20 other device types. 18 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
22device types registered with the FDA
18products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016426842 |
| FEI number | 3016426842 |
| DUNS | 550402542 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 山东海迪科医用制品有限公司 |
|---|---|
| Unified social credit code | 91371722059049941D |
| Source | NMPA UDI database |
Location
| City | Heze |
|---|---|
| Province | Shandong |
| Address | Tianfu Road, Dongcheng District, Shan County |
| Postal code | 274300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Medical isolation mask | 2020 | 439 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Sampling swab | 2020 | 100 |
| Bandage, Elastic | Class 1 | elastic bandage | 2019 | 280 |
| Bedding, Disposable, Medical | Class 1 | Medical bed cover | 2020 | 308 |
| Cap, Surgical | Class 1 | Medical Cap | 2020 | 178 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Sampling tube | 2020 | 51 |
| Cover, Shoe, Operating-Room | Class 1 | Medical Isolation Shoe Cover | 2020 | 176 |
| Dressing, Wound, Hydrophilic | Class 1 | band-aid | 2019 | 195 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Disposable medical face mask | 2020 | 182 |
| Mask, Surgical | Class 2 | Surgical Face Mask | 2021 | 125 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
| Pack, Hot Or Cold, Disposable | Class 1 | Medical cold compress | 2019 | 176 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Medical Goggle | 2020 | 384 |
| Splint, Traction | Class 1 | medical polymer splint | 2019 | 27 |
| Staple, Removable (Skin) | Class 1 | Skin Staple Remover | 2026 | 20 |
| Stapler, Skin | Class 1 | Disposable Skin Stapler | 2024 | 22 |
| Suture, Nonabsorbable, Silk | Class 2 | Non absorbable Surgical Silk Suture | 2024 | 4 |
| Suture, Nonabsorbable, Synthetic, Polyamide | Class 2 | Non Absorbable Surgical Nylon Suture | 2021 | 3 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | Class 2 | Non-absorbable Surgical Polyester Suture | 2023 | 6 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | Class 2 | Non absorbable Surgical Polypropylene Suture | 2023 | 3 |
| Tape And Bandage, Adhesive | Class 1 | polymer fixed bandage | 2019 | 353 |
| Walker, Mechanical | Class 1 | walking aid | 2021 | 183 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Rtmed | GAR | 41 |
| Rtmed | GAT | 39 |
| Rtmed | GAW | 35 |
| Rtmed | GAP | 34 |
| Rtmed | IMD | 2 |
| Rtmed | NNK | 2 |
| Rtmed | FQM | 2 |
| Rtmed | NAC | 2 |
| Rtmed | OEA | 2 |
| Rtmed | FXX | 2 |
| Rtmed | HSP | 2 |
| Rtmed | KGX | 2 |
| Rtmed | LYU | 1 |
| Rtmed | FYF | 1 |
| Rtmed | HOY | 1 |
| Rtmed | FXP | 1 |
| Rtmed | KXG | 1 |
| Rtmed | KME | 1 |
Clearances
3 clearances name Shandong Haidike Medical Products Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230746 | 2023-09-14 | GAW | Traditional | This company |
| K231183 | 2023-08-25 | GAT | Traditional | This company |
| K210518 | 2021-06-14 | FXX | Traditional | This company |
| K232355 | 2024-01-16 | GAP | Traditional | Shandong Haidike Medical Product Co., Ltd. |
| K212603 | 2021-12-22 | GAR | Traditional | Shandong Haidike Medical Product Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Employees | 102 |
| Main products | Medical sutures, Surgical instruments, Medical consumables |
| Export markets | 30+ countries |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | 65 |
| Coda Resources Ltd., Heze China | 9 |
| Shandong Caremed Medical Products Co., Ltd. | 6 |
| Biobase Medfuture Scientific Equipment Co., Ltd. | 5 |
| Shandong Shangwei Medical Products Co., Ltd. | 3 |
| Shandong Jieshi Medical Products Co., Ltd. | 2 |
| Shandong Xiaokang Biotechnology Co., Ltd. | 1 |
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.
The manufacturer named here can complete this record.