Identity
- Trade Name
- Wealy FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Device Name
- Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection. FDA UDI
- Model / Reference
- 3ml 25Gx1" FDA UDI
- Description
- Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971603580500 FDA UDI
- 510(k) Number
- K141640 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Ethylene Oxide FDA UDI
Category: Metered-delivery hypodermic syringe
Wealy by Shantou Wealy Medical Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metered-delivery hypodermic syringe.
- TERUMO — Terumo (Philippines) Corporation · Class II
- SURGUARD2 — Terumo (Philippines) Corporation · Class II
- ZevRx STERILE INSULIN SYRINGE 5/16” | 1/2CC | 30G — HOME AIDE DIAGNOSTICS, INC. · Class II
- Syringe with needle — ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD · Class II
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- Monoject — Cardinalhealth · Class II
- Jelco — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K141640 also covers:
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shantou Wealy Medical Instrument Co., Ltd.
Sources (1)
- FDA UDI 98ad80c6-e423-4939-873e-f4ec58aff6fc 34 fields · synced May 30, 2026