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IMPROSAFE Blood Collection Set with Pre-Attached Holder
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 596122302Model 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”Ref 596125192Ref 596124302
Identity
- Trade Name
- IMPROSAFE Blood Collection Set with Pre-Attached Holder EUDAMED
- Device Name
- IMPROSAFE® Blood Collection Set with Pre-Attached Holder 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” EUDAMED596122302 EUDAMED596125192 EUDAMED596124302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974481831672 EUDAMED06974481831085 EUDAMED06974481831696 EUDAMED
- Basic UDI-DI
- 697448183001005UY EUDAMED
- EMDN Code
- A010199 NEEDLES FOR INFUSION AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
IMPROSAFE Blood Collection Set with Pre-Attached Holder by Guangzhou Improve Medical Instruments Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153388 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697448183001005UY | Class IIa | Active |
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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 (4)
- EUDAMED 571db49d-69f4-4a16-a577-f86da0a843f8 61 fields · synced Jul 17, 2026
- EUDAMED dec51ecc-96c5-425b-8e91-05cf8ad7644c 61 fields · synced May 19, 2026
- EUDAMED d48ae760-8ef9-402f-bf80-20ca5f6cfff0 61 fields · synced May 19, 2026
- FDA 510(k) K153388 1 fields · synced Jun 9, 2026