← Back to catalogue
Safety Blood Collecting Needle
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 004BModel Pen type (with or w/o needle holder), Flashback Type, Double-wing type (with or w/o holder)
Identity
- Trade Name
- Safety Blood Collecting Needle EUDAMED
- Device Name
- Safety Blood-collecting needles EUDAMED
- Model / Reference
- Pen type (with or w/o needle holder), Flashback Type, Double-wing type (with or w/o holder) EUDAMED004B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923033416881 EUDAMED
- Basic UDI-DI
- 69230334202002a00802MN EUDAMED
- EMDN Code
- A01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
Safety Blood Collecting Needle by Zhejiang Kindly Medical Devices Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K172763 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69230334202002a00802MN | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007594
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 6e6d6ee4-757f-4105-8d3c-d13402e08af7 61 fields · synced Oct 6, 2026
- FDA 510(k) K172763 1 fields · synced May 18, 2026