China National Medicines & Health Prod. I/E Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “China National Medicines & Health Prod. I/E Corp.” (first 1987, latest 1991), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 27 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 3 | 3 |
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| FNJ | Bed, Manual | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| HIS | Condom | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (5)
- General and Plastic Surgery (2)
- Obstetrics and Gynecology (1)
- Physical Medicine (1)
Most recent China National Medicines & Health Prod. I/E Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902324 | TP AND DESIGN, CONDOM | HIS | 1991-03-29 | 309 |
| K893351 | LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX) | LYY | 1989-11-17 | 210 |
| K892916 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-07-14 | 93 |
| K891365 | LATEX EXAMINATION GLOVES, NON-STERILE | LYY | 1989-04-26 | 47 |
| K870315 | WHITE PLUME ABSORBENT BANDAGE | — | 1987-02-24 | 27 |
| K870314 | WHITE PLUME GAUZE SPONGE | EFQ | 1987-02-24 | 27 |
| K870312 | WHITE PLUME SURGICAL GAUZE FACE MASK | FXX | 1987-02-24 | 27 |
| K870309 | WHITE PLUME ABSORBENT COTTON WOOL | — | 1987-02-24 | 27 |
| K870308 | WHITE PLUME ABSORBENT GAUZE | EFQ | 1987-02-24 | 27 |
| K870306 | WHITE PLUME TRIANGULAR BANDAGE | — | 1987-02-24 | 27 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named China National Medicines & Health Prod. I/E Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- China Xinxing Corp. , Ltd. (3 510(k)s)
- China Daheng Group, Inc. (2 510(k)s)
- China National Chemical Construction Corp.-Qingdao (2 510(k)s)
- China Chongqing Bashan Instrument Factory (1 510(k)s)
- China Healthways Institute (1 510(k)s)
- China Link, Inc. (1 510(k)s)
- China Nantong Guangda Textile Co., Ltd. (1 510(k)s)
- China National Chemicals Import & Export (Liaoning (1 510(k)s)
- China National Machinery & Equipment Import & Expo (1 510(k)s)
- China National Medicines C/O Havel'S (1 510(k)s)
- China North Industries Corp. (1 510(k)s)
- China Representatives , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under China National Medicines & Health Prod. I/E Corp.?
FDA lists 12 510(k) clearances under the applicant name “China National Medicines & Health Prod. I/E Corp.” (first 1987, latest 1991), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by China National Medicines & Health Prod. I/E Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name China National Medicines & Health Prod. I/E Corp. is 27 days.
Which FDA product codes appear under China National Medicines & Health Prod. I/E Corp.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 3); EFQ (Gauze/Sponge, Internal, 2); FNJ (Bed, Manual, 1).
Next steps
- See all 12 China National Medicines & Health Prod. I/E Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, China National Medicines & Health Prod. I/E Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.