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IMPROSAFE® Blood Collection Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 596123300Model 21G × 3/4” × 12”; 22G × 3/4ʺ × 12ʺ; 23G × 3/4” × 12”; 24G × 3/4ʺ × 12ʺ; 25G × 3/4” × 12”; 21G × 3/4” × 7”; 22G × 3/4ʺ × 7ʺ; 23G × 3/4” × 7”; 24G × 3/4ʺ × 7ʺ; 25G × 3/4” × 7”
Identity
- Trade Name
- IMPROSAFE® Blood Collection Set EUDAMEDFDA UDI
- Generic Name
- Non-fixed blood collection needle FDA UDI
- Device Name
- IMPROSAFE® Blood Collection Set EUDAMED
- Model / Reference
- 21G × 3/4” × 12”; 22G × 3/4ʺ × 12ʺ; 23G × 3/4” × 12”; 24G × 3/4ʺ × 12ʺ; 25G × 3/4” × 12”; 21G × 3/4” × 7”; 22G × 3/4ʺ × 7ʺ; 23G × 3/4” × 7”; 24G × 3/4ʺ × 7ʺ; 25G × 3/4” × 7” EUDAMED596123300 EUDAMED23G x 3/4” x 12” FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974481830958 EUDAMEDFDA UDI
- Basic UDI-DI
- 697448183001004UW 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
- Non-fixed blood collection needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
IMPROSAFE® 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 | 697448183001004UW | 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 e26dccaf-8c75-4aa8-8cec-43fac7731dee 61 fields · synced Jul 18, 2026
- FDA UDI ba1dc814-459a-4c5d-b6ab-17fa854cfe59 33 fields · synced May 29, 2026