Identity
- Trade Name
- EasyPoint Needle EUDAMEDEasyPoint® FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- EasyPoint Needle EUDAMED25G x 1" EasyPoint® Needle FDA UDI
- Model / Reference
- 85211 EUDAMEDFDA UDI
- Description
- 25G x 1" EasyPoint® Needle FDA UDI
Identifiers
- Catalog Number
- 85211 FDA UDI
- Primary DI / UDI-DI
- 00613703852106 EUDAMEDFDA UDI
- Basic UDI-DI
- 0613703EasyPoint2B EUDAMED
- 510(k) Number
- K133635 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Germany 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
Yes
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
EasyPoint Needle by Retractable Technologies, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K133635 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0613703EasyPoint2B | Class IIa | Active |
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Manufacturer
- Manufacturer
- Retractable Technologies, Inc.
- EUDAMED SRN
- US-MF-000031781
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 15452817-8fed-43f3-9818-1307f33a8c3c 61 fields · synced Jun 20, 2026
- FDA UDI bf6750c9-d5d9-4403-8fb7-03432ca24bc3 36 fields · synced May 30, 2026
- FDA 510(k) K133635 1 fields · synced May 18, 2026