FDA Registration
Active
🇨🇳 China
SHANDONG DEMAN MEDICAL EQUIPMENT GROUP CO., LTD
Reg #: 3029970239
·
FEI: 3029970239
·
Expires 2026
Products
11
Proprietary Names
20
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- SHANDONG DEMAN MEDICAL EQUIPMENT GROUP CO., LTD
- Registration Number
- 3029970239
- FEI Number
- 3029970239
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Xiaomeng Town Industrial Park, Yanzhou District
- City
- Jining City Shandong
- Country
- CN
Owner / Operator
- Firm Name
- Shandong Deman Medical Equipment Group Co., LTD
- Operator Number
- 10088802
- Address
- Xiaomeng Town Industrial Park, Yanzhou District
- City
- Jining City
- State
- Shandong
- Postal Code
- 272100
- Country
- CN
- Correspondent
- XiuLan Zhang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2024-11-21 |
| Accessories To Examination Light | PEQ | Class 1 | General Hospital | No | 2024-11-21 |
| Table, Mechanical | INW | Class 1 | Physical Medicine | No | 2025-12-14 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2023-10-12 |
| Table, Operating-Room, Manual | FSE | Class 1 | General, Plastic Surgery | No | 2024-03-27 |
| Chair, Blood Donor | FML | Class 1 | General Hospital | No | 2025-12-14 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2023-10-12 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2025-12-14 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2024-03-27 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2024-11-21 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2023-10-12 |
Proprietary Names
Expandable Rolling Bath Tub (MF-1111)
Medical viewing light (DM-I, DM-II, DM-III, DM2-I, DM2-II, DM2-III)
Gynecological Examination Beds: AF-01, AF-02, AF-03
Manual Hospital Beds: AA-3, AA-6, AA-7, AA-8, AA-8-H, APE-4, APE-6, APE-7, APE-10, APE-11, APE-13, APE-14, APE-15, A0-1,
A0-2, A0-6, A0-7, A0-8, A0-9, AP-1, AP-2, AP-8, AP-9, A31, A32, A33, A34, A35, A36, AD-7, AD-8, AD-8M, ZD-01, ZD-02,
ZD-03, FS-01
Hydraulic comprehensive operating table (SST-1, SST-2, SST-3);
Multiopurpose Operating Table (ZST-1, ZST-2, ZST-3, ZST-4, ZST-5, ZST-6)
Manual Dialysis Chair: TY-01, TY-02
DST-600, DST-600T, DST-700T, DST-600E, DST-600A, DST-700A, DST-1100
Electric Surgical Tables: DST- 1A, DST- 2, DST-3, DST- 3003, DST- 3004, DST- 5, DST- 500A, DST- 700, DST- 700G, JR-9000,
Transport Vehicles: AB-01, AB-02, AB-03, AB-04
YDZ500/500, YDZ700/700, YDZ700, YDZ500, YDZ700D, YDZ500D, YDZ300D);
Operation Illuminating Lamp (YDZ700B, YDZ500B, YDE300, YDE200, YDE180, YDE120, YDE50, YDE300D, YDE200D, YDE180D,
Surgical Shadowless Lamps (YDE700/500, YDE700/700, YDE500/500, YDE700, YDE500, YDE700D, YDE500D, YDE300D, YDZ700/500,
YDE120D, YDE50D, YDE300B, YDE200B, YDE180B, YDE120B, YDE50B, YDE700, YDE500, YDE400, YDE300, YDE200, YDE100D, YDE60D)
DMYL-3600, DMYL-3600-2, DMYL-3600D, DMYL-3600-2D, DMYL-580, DMYL-580Y, DMYL-180-X, DMYL-180X, DMYL-180-E/X,
Medical Pendant suspension bridge (DM-Y, DMYL-3200, DM-3200-2, DMYL-3200-M, DMYL-3200-2M, DMYL-3200D, DMYL-3200-2D,
DMYL-180-E/E, DMYL-180-E-1, DMYL-180-E-2, DMYL-suspension bridge (conjoined))
Electric Hospital Beds: DHC-I, DHC-II, DHC-III, DHC-IV, DHC-V, DHC-VI, DHC-VII, DHC-VIII, DHC-IX, DHC-X
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device