Weihai Kangzhou Biotechnology Engineering Co., Ltd.
Manufacturer and brand owner in Weihai, Shandong, China. 24 device types, 14 products catalogued, 1 clearance.
Weihai Kangzhou Biotechnology Engineering Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Dress, Surgical, Mask, Scavenging and 22 other device types. 14 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
24device types registered with the FDA
14products catalogued under its own name
1510(k) clearance
Registration
| Registered name | WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014171027 |
| FEI number | 3014171027 |
| DUNS | 560448061 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 威海康州生物工程有限公司 |
|---|---|
| Unified social credit code | 913710000659164741 |
| Source | NMPA UDI database |
Location
| City | Weihai |
|---|---|
| Province | Shandong |
| Address | (Room 401-402, Building B, Innovation Base) No. 213-3, Huoju Road, |
| Postal code | 264205 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Surgical drape, Nitro coated disposable gloves, disposable gloves, PVC disposable gloves, Medical disposable gloves | 2017 | 439 |
| Antigens, All Groups, Salmonella Spp. | Class 2 | Typhoid | 2017 | 1 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Disposable Sampling swab | 2020 | 186 |
| Dress, Surgical | Class 1 | Surgical Gown | 2017 | 71 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Disinfectant wipes, Multi purpose antibacterial, Alcohol Wipes | 2024 | 266 |
| Kit, Screening, Urine | Class 1 | Urine Test Strip | 2017 | 7 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | My Baby pregnancy test MidstreamHCG-03, Personal CARE 1 STEP HCG Urine Pregnancy Test Cassette,, MaYa One Step HCG Pregnancy Test, One Step hCG Test Strip, One Step hCG Test Cassette, One Step hCG Test Midstream,, U Pregnancy Test, My Baby pregnancy test Strip HCG-01, My Baby pregnancytest Cassette HCG-02,, Personal care ONE STEP HCG URINE PREGNANCY TEST, Clarisse ONE STEP HCG URINE PREGNANCY TEST | 2019 | 30 |
| Mask, Scavenging | Class 1 | Face Mask | 2017 | 158 |
| Non-Surgical Gown | Class 1 | Isolation gown | 2017 | 318 |
| Pack, Hot Or Cold, Disposable | Class 1 | cooling gel patch | 2017 | 176 |
| Radioimmunoassay, Luteinizing Hormone | Class 1 | LH ovulation test, My baby Ovulation kit Strip LH-01, My baby Ovulation kit Cassette LH-02,, My baby Ovulation kit Midstream LH-03 | 2017 | 16 |
| Tape And Bandage, Adhesive | Class 1 | Pain relieving plaster | 2018 | 353 |
| Test, Barbiturate, Employment And Insurance Testing, Exempt | Class 2 | Barbiturates test strip/cassette/cup | 2018 | 11 |
| Test, Benzodiazepine, Employment And Insurance Testing, Exempt | Class 2 | Benzodiazepines test strip/cassette/cup | 2018 | 11 |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | Class 2 | marijuana test strip/cassette/cup | 2018 | 12 |
| Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt | Class 2 | Cocaine test strip/cassette/cup | 2018 | 12 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | FSH Test | 2017 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | LH ovulation test, My baby Ovulation kit Strip LH-01, My baby Ovulation kit Cassette LH-02,, My baby Ovulation kit Midstream LH-03 | 2026 | 38 |
| Test, Methadone, Employment And Insurance Testing, Exempt | Class 2 | methadone test strip/cassette/cup | 2018 | 11 |
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | Class 2 | amphetamine test strip/cassette/cup, Methylenedioxy methamphetamine test strip/cassette/cup, Methamphetamine test strip/cassette/cup, | 2018 | 13 |
| Test, Morphine, Employment And Insurance Testing, Exempt | Class 2 | morphine test strip/cassette/cup | 2018 | 8 |
| Test, Opiates, Employment And Insurance Testing, Exempt | Class 2 | Opiate test strip/cassette/cup | 2018 | 12 |
| Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt | Class 2 | Tricyclic antidepressants test strip/cassette/cup | 2018 | 7 |
| Tube, Collection, Capillary Blood | Class 1 | Capilarry Blood Collection Tube | 2017 | 16 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Ferticare | NGE | 9 |
| Ferticare | LCX | 8 |
| Super-AID | LCX | 2 |
| kangzhou | LCX | 1 |
| kangzhou | PVJ | 1 |
| Oichid | LCX | 1 |
| Instant Aid By PUR-est | CEP | 1 |
| Sims ovulation test kit | CEP | 1 |
| MaYa | LCX | 1 |
| Instant Aid By PUR-est | LCX | 1 |
| Universal | LCX | 1 |
| Personal Care | LCX | 1 |
| Zioxx | LCX | 1 |
| Sims pregnancy test kit | LCX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K183097 | 2019-01-10 | LCX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | HCG pregnancy test, LH ovulation test, drug test, disease test, coronavirus detection kit |
| Certifications | CE, MHRA, ISO 13485 |
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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