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IMPROVACUTER® Needle Holder
EUDAMEDFDA UDIClass I (EU MDR)
Ref 582010Model General；With safety shield
Identity
- Trade Name
- IMPROVACUTER® Needle Holder EUDAMEDNeedle Holder FDA UDI
- Generic Name
- Blood collection tube holder/needle FDA UDI
- Device Name
- Needle Holder EUDAMED
- Model / Reference
- General；With safety shield EUDAMED582010 EUDAMEDWith safety shield FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974481839142 EUDAMEDFDA UDI
- Basic UDI-DI
- 697448183006001VT EUDAMED
- FDA Product Code
- KST FDA UDI
- EMDN Code
- A01018001 HOLDERS FOR COLLECTION NEEDLES EUDAMED
- GMDN Term
- Blood collection tube holder/needle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.9125 FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
IMPROVACUTER® Needle Holder by Guangzhou Improve Medical Instruments Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697448183006001VT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Improve Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000006536
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e5ce1fc7-0932-4159-ab0e-1ce33d3f29df 61 fields · synced Jun 18, 2026
- FDA UDI e58b7f56-72b2-4d31-9885-4e9f1f4eac83 32 fields · synced May 30, 2026