Changzhou Holymed Products Co., Ltd
CHANGZHOU Jiangsu, CN
CHANGZHOU HOLYMED PRODUCTS CO., LTD appears in FDA device records in CHANGZHOU Jiangsu, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Changzhou Holymed Products Co., Ltd between 2012 and 2021. The busiest year on record is 2012, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210524 | Surgical Mask | FXX | Substantially Equivalent | |
| K121998 | HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED | FYA | Substantially Equivalent | |
| K122000 | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER | KKX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006891803 | 3006891803 | CHANGZHOU HOLYMED PRODUCTS CO., LTD | 525 CHANGWU ROAD SOUTH, CHANGZHOU Jiangsu 213167 CN | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- KYRBag, Ice
- KMEBedding, Disposable, Medical
- GECBrush, Scrub, Operating-Room
- FYFCap, Surgical
- FXPCover, Shoe, Operating-Room
- KKXDrape, Surgical, Antimicrobial
- PUIDrape, Surgical, Exempt
- NABGauze / Sponge,Nonresorbable For External Use
- LROGeneral Surgery Tray
- FMEGown, Examination
- FYAGown, Surgical
- BSJMask, Gas, Anesthetic
- FXXMask, Surgical
- OEANon-Surgical Gown
- BWPShoe And Shoe Cover, Conductive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain