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IMPROVACUTER® Blood Collection Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 594125300Model 21G×3/4″×7″;22G×3/4″×7″;23G×3/4″×7″;25G×3/4″×7″;21G×3/4″×12″;22G×3/4ʺ×12″;23G×3/4″×12″;25G×3/4″×12″
Identity
- Trade Name
- IMPROVACUTER® Blood Collection Set EUDAMEDFDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- Blood Collection Needle EUDAMED
- Model / Reference
- 21G×3/4″×7″;22G×3/4″×7″;23G×3/4″×7″;25G×3/4″×7″;21G×3/4″×12″;22G×3/4ʺ×12″;23G×3/4″×12″;25G×3/4″×12″ EUDAMED594125300 EUDAMED25G×3/4”×12” FDA UDI
Identifiers
- Catalog Number
- 594125300 FDA UDI
- Primary DI / UDI-DI
- 06974481830835 EUDAMEDFDA UDI
- Basic UDI-DI
- 697448183001007V4 EUDAMED
- 510(k) Number
- K153388 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A010199 NEEDLES FOR INFUSION AND COLLECTION - OTHER EUDAMED
- GMDN Term
- Blood collection set, invasive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Cyprus EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
IMPROVACUTER® Blood Collection Set by Guangzhou Improve Medical Instruments Co., Ltd. — Class IIa — 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 | 697448183001007V4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 fb4d444a-6d58-4afe-9d41-6a7322bf2e76 61 fields · synced May 31, 2026
- FDA UDI 5bdff8ec-735b-49d7-b86c-39834424a1dc 34 fields · synced May 30, 2026