AcuZone AZ 1-35100
by Wujiang City ShenLing Medical Device Co., Ltd
AcuZone AZ 1-35100 is an acupuncture needle (FDA Class II; FDA product code MQX, Needle, Acupuncture, Single Use) made by Wujiang City ShenLing Medical Device Co., Ltd, cleared under FDA 510(k) K002411 on 12 Dec 2000 and listed in FDA GUDID since 21 Dec 2017 (UDI-DI B491AZ1351001), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB491AZ1351001 | Date21 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK002411 | Date12 Dec 2000 | StatusActive |
Official records
- FDA 510(k) database K002411
Across registries
- FDA 510(k) K002411 decided 12 Dec 2000 Active
- FDA GUDID UDI-DI B491AZ1351001 listed 21 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K002411
- Listed FDA GUDID B491AZ1351001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AcuZone
- Generic name
- Acupuncture needle, single-use
- Model / Ref / Catalog
- AZ 1-35100
- Primary DI / UDI-DI
- B491AZ1351001
- 510(k) Number
- FDA product code
- MQX
- GMDN term
- Acupuncture needle, single-use
- Device class
- Class II
- Regulation number
- 880.5580
- GUDID distribution status
- In Commercial Distribution
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- EACU, EAKU, ZAGU, JOCU CJ3575 by Maanshan Bond Medical Instruments Co., Ltd.
- EACU, EAKU, ZAGU, JOCU CJ3050 by Maanshan Bond Medical Instruments Co., Ltd.
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