Needle Holder Quick Release
by Guangzhou Improve Medical Instruments Co., Ltd. EUDAMEDGUDID
Active
Ref 584010Model IMPROVACUTER® Needle Holder (Quick Release)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06974481839166 | Date21 Sep 2026 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number697448183006002VV | Date14 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- Trade Name
- IMPROVACUTER® Needle Holder (Quick Release) EUDAMEDNeedle Holder GUDID
- Generic Name
- Blood collection set, invasive
- Model / Ref / Catalog
- IMPROVACUTER® Needle Holder (Quick Release), 584010, Quick Release
- Primary DI / UDI-DI
- 06974481839166
- Basic UDI-DI
- 697448183006002VV
- FDA Product Code
- KST
- EMDN Code
- A01018001 Holders for collection needles
- GMDN Term
- Blood collection set, invasive
- Device Class
- Class I
- Regulation Number
- 864.9125
- Market of Registration
- Poland
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | IMPROVACUTER® Needle Holder (Quick Release) 584010 | Quick Release |
Other devices from Guangzhou Improve Medical Instruments Co., Ltd.
See all devices from Guangzhou Improve Medical Instruments Co., Ltd. →
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No