FDA Registration
Active
🇨🇳 China
HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3030683078
·
FEI: 3030683078
·
Expires 2026
Products
10
Proprietary Names
94
Establishment Types
1
Classifications
10
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Registration Details
- Registration Name
- HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3030683078
- FEI Number
- 3030683078
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 2 of 53-4 Xiyang Road, Tongan District
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- HuiLing (Xiamen) Medical Technology Co., Ltd.
- Operator Number
- 10090246
- Address
- Unit E-3, 4th Floor, Beilongxin Building, No.8 Xinfeng 2nd Road, Torch Park, Torch High-tech Zone
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361006
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-12-08 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2025-12-08 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2024-03-01 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2024-03-01 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2025-12-08 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2025-12-08 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2025-12-09 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2025-12-09 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2025-12-08 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2025-12-09 |
Proprietary Names
model: HL42008, specification: Universal
model: HL035, specification: S-L/R, M-L/R, L-L/R XL-L/R
model: HL42007, specification: Universal
model: HL42001, specification: Universal
model: HL047, specification: Universal
Knee Orthosis
model: HL045, specification: S, M, L, XL, XXL, XXXL
model: HL42011, specification: Universal
model: HL42003, specification: Universal
model: HL018, specification: Universal
model: HL017, specification: Universal
model: HL036, specification: S-L/R, M-L/R, L-L/R XL-L/R
model: HL023, specification: Universal
model: HL024, specification: Universal
model: HL051, specification: Universal
model: HL052, specification: Universal
Cervical Brace, Orthosis
model: HL6506 , specification: Universal
model: RDS15 , specification: Universal
model: HL12007, specification: Universal
Behind The Ear Hearing Aid( OTC), HL1ON, HL10,HL20,HL30,HL40,HL50, HL15N,HL15,HL25,HL35,HL45,HL55
IN THE EAR HEARING Aid, HL12L,HL12R,HL22L,HL22R
Behind The Ear Hearing Aid( OTC), HL11N,HL11,HL21,HL31,HL41,HL51,HL11PN,HL11P,HL21P,HL31P,HL41P,HL51P
Behind The Ear Hearing Aid( OTC), HL15PN,HL15P,HL25P,HL35P,HL45P,HL55P, HL15UN,HL15U,HL25U,HL350,HL450,HL.550
Behind The Ear Hearing Aid (OTC), HL22N,HL22,HL32,HL52,HL62,HL72,HL82,HL92
model: HL60241, specification: S-L/R, M-L/R, L-L/R XL-L/R
model: HL52005, specification: S-L/R, L-L/R
model: HL6052, specification: Universal
model: HL82018, specification: Universal
model: HL003, specification: Universal-L/R
Lower Limb Orthosis
model: HL52006, specification: S-L/R, L-L/R
model: HL52015, specification: S, M, L
model: HL52014, specification: S, M, L, XL
model: HL82010, specification: Universal
Upper Limb Orthosis
model: HL048, specification: Universal
model: HL13131, specification: S-L/R, L-L/R
model: HL83010, specification: Universal-L/R
model: HL012, specification: S, M, L, XL, XXL
model: HB09, specification: S, M, L, XL, XXL
Lumbo-sacral Orthosis
model: HL22076, specification: Universal
model: HL70002, specification: S, M, L, XL, XXL
model: HL70007, specification: S, M, L, XL, XXL
model: HL70006, specification: S, M, L, XL, XXL
model: HL046, specification: S, M, L, XL, XXL
model: HL32007, specification: Universal
model: HL013, specification: S, M, L, XL, XXL
model: HL70004, specification: S, M, L, XL, XXL
model: BST07, specification: S, M, L, XL, XXL
model: BST08, specification: S, M, L, XL, XXL
model: HB10 specification: S, M, L, XL, XXL
model: HL70003, specification: S, M, L, XL, XXL
Chest Orthosis
model: HL1903, specification: S, M, L, XL
model: HL001, specification: Universal
model: MLK01, specification: Universal
model: HL027, specification: S, L
model: HL86222, specification: S, M, L
model: HL22003, specification: Universal
model: HL060, specification: S, M, L
model: HL22005, specification: Universal
Finger Orthosis
Model: HL031, Specifications: S, M, L
Model: HL042, Specifications: S, M, L
Model: HL52036, Specifications: S, M, L,XL
Model: HL030, Specifications: S, M, L,XL
Model: HL006, Specifications: S, M, L
Foot Orthosis
Model: HL007, Specifications: S, M, L
Model: HL029, Specifications: S, M, L,XL
Model: HL52069, Specification: Universal
Model: HL52015 , Specifications: S, M, L
Model: HL008, Specifications: S, M, L
Model: HL041, Specifications: S, M, L
Model: HL037, Specifications: S, M, L
Model: HL52004, Specifications: S-L/R, L-L/R
Model: HL52006, Specifications: S-L/R, L-L/R
Model: HL010, Specifications: S, M, L
Model: HL032, Specifications: S, M, L
Model: TY04, Specifications: S-L/R, M-L/R, L-L/R, XL-L/R
Model: HL52005, Specifications: S-L/R, L-L/R
Model: HL52017, Specifications: S, M, L
Model: HL60241, Specifications: S-L/R, M-L/R, L-L/R, XL-L/R
Model: HL52002, Specifications: XS-L/R,S-L/R,L-L/R
Model: HL009, Specifications: S, M, L
Model: HL52014, Specifications: S, M, L
Model: HL52001, Specifications: S-L/R, M-L/R, L-L/R
Model: TY03, Specifications: S-L/R, L-L/R
model: HLB026, specification: S, M, L, XL, XXL
model: HLB019 , specification: S, M, L, XL, XXL
Lumbar Orthotics
model: HLB002, specification: Universal
Establishment Types
Manufacture Medical Device