FDA Registration
Active
🇨🇳 China
SHANGHAI BOJIN MEDICAL INSTRUMENT CO., LTD.
Reg #: 3037027197
·
FEI: 3037027197
·
Expires 2026
Products
5
Proprietary Names
328
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SHANGHAI BOJIN MEDICAL INSTRUMENT CO., LTD.
- Registration Number
- 3037027197
- FEI Number
- 3037027197
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- A Zone of F2, C Zone of F1, Building 6, No.125, Longpan Road, Jiading District, Shanghai, China
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai Bojin Medical Instrument Co., Ltd.
- Operator Number
- 10091813
- Address
- A Zone of F2, C Zone of F1, Building 6, No.125, Longpan Rd, Jiading District, Shanghai, China
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201801
- Country
- CN
- Correspondent
- QINGYUAN WANG
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 |
|---|---|---|---|---|---|
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2025-06-25 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2025-02-25 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2026-03-31 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-02-25 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-02-25 |
Proprietary Names
KR-A
KR-C
KR-B
EPM Mueller LTC.; MIS And Mini; Reamer; Reamer ST
Saw blades(Non-Sterile) -YBSF
Saw blades(Sterile) -NF
Saw blades(Non-Sterile) -2SF
Saw blades(Non-Sterile) -GF
Saw blades(Sterile) -YBSF
Saw blades(Non-Sterile) -2SOF
Saw blades(Non-Sterile) -GFG
Saw blades(Sterile) -YBSFD
Saw blades(Non-Sterile) -BJ
Saw blades(Sterile) -SOF
Saw blades(Non-Sterile) -2BF
Saw blades(Sterile) -BF
Saw blades(Sterile) -JSO
Saw blades(Sterile) -WF
Saw blades(Non-Sterile) -3S
Saw blades(Sterile) -2HF
Saw blades(Sterile) -SM
Saw blades(Sterile) -2GF
Saw blades(Sterile) -SG
Saw blades(Non-Sterile) -WF
Saw blades(Sterile) -2XA
Saw blades(Sterile) -H
Saw blades(Sterile) -SSW
Saw blades(Non-Sterile) -YBSFD
Saw blades(Sterile) -S
Saw blades(Sterile) -2BF
Saw blades(Sterile) -SF
Saw blades(Non-Sterile) -SOF
Saw blades(Sterile) -EF
Saw blades(Non-Sterile) -NF
Saw blades(Non-Sterile) -XS
Saw blades(Sterile) -JSOSW
Saw blades(Sterile) -2H
Saw blades(Sterile) -SJCZ
Saw blades(Non-Sterile) -SSG
Saw blades(Sterile) -2S
Saw blades(Sterile) -ESG
Saw blades(Non-Sterile) -2XA
Saw blades(Non-Sterile) -H
Saw blades(Non-Sterile) -BJ3501
Saw blades(Non-Sterile) -BF
Saw blades(Sterile) -SO
Saw blades(Non-Sterile) -SO
Saw blades(Sterile) -DJSO
Saw blades(Non-Sterile) -DE
Saw blades(Non-Sterile) -SF
Saw blades(Non-Sterile) -DESO
Saw blades(Non-Sterile) -SG
Saw blades(Non-Sterile) -M
Saw blades(Non-Sterile) -XA
Saw blades(Non-Sterile) -2GF
Saw blades(Sterile) -BJ
Saw blades(Sterile) -WFSW
Saw blades(Non-Sterile) -SW
Saw blades(Sterile) -2SOF
Saw blades(Sterile) -GFG
Saw blades(Sterile) -SSG
Saw blades(Non-Sterile) -SSW
Saw blades(Sterile) -2SF
Saw blades(Sterile) -GF
Saw blades(Non-Sterile) -S
Saw blades(Non-Sterile) -YBF
Saw blades(Sterile) -M
Saw blades(Non-Sterile) -EF
Saw blades(Non-Sterile) -SM
Saw blades(Sterile) -DESO
Saw blades(Sterile) -3S
Saw blades(Sterile) -HF
Saw blades(Sterile) -SW
Saw blades(Non-Sterile) -BJ3301
Saw blades(Non-Sterile) -2H
Saw blades(Sterile) -BJ3301
Saw blades(Sterile) -XA
Saw blades(Non-Sterile) -HF
Saw blades(Non-Sterile) -2HF
Saw blades(Sterile) -BJ3501
Saw blades(Sterile) -XS
Saw blades(Non-Sterile) -JSO
Saw blades(Non-Sterile) -JSOSW
Saw blades(Non-Sterile) -WFSW
Saw blades(Non-Sterile) -2S
Saw blades(Non-Sterile) -ESG
Saw blades(Sterile) -CSW
Saw blades(Sterile) -YBF
Saw blades(Non-Sterile) -DJSO
Saw blades(Non-Sterile) -SJCZ
Saw blades(Sterile) -DE
Saw blades(Non-Sterile) -CSW
BYZ-II 1102 (BJ1102SAO) High speed bone drill
BYJZ-I 52 (BJ5200) Multi-functional Handpiece
BYJZ-I 54 (BJ5400) Multi-functional Handpiece
BYJZ-I 56 (BJ5613B) Pin and wire driver attachment
BYJZ-I 84 (BJ8402S) High-speed drill attachment
BYJZ-I 66 (BJ6603D) Cannulated drill attachment(Large AO coupling)
BJ5513A-A Pin and wire driver attachment
BYJZ-I 21 (BJ2107D) Acetabulum reamer attachment
BYJZ-I 42 (BJ4202SAO) Small AO drill attachment
BYJZ-I 54 (BJ5410) Torque limiter attachment
BYZ-II 5503 (BJ5503S) Dual functional cannulated drill
BYJZ-I 21 (BJ2107S) Acetabulum reamer attachment
BYJZ-I 42 (BJ4203B) Cannulated drill attachment
BYJZ-I 54 (BJ5410S) Torque limiter attachment
BYJ-II 5506 (BJ5506) Reciprocating saw (Sternum saw)
BYJZ-I 21 (BJ2102) High-speed drill attachment
BYJZ-I 21 (BJ2112) Oscillating saw attachment
BYZ-II 4107 (BJ4107D) Acetabulum reaming drill
BYJZ-I 54 (BJ5402SB) High-speed drill attachment
BYJZ-I 54 (BJ5413A) Pin and wire driver attachment
BYJZ-I 66 (BJ6613B) Pin and wire driver attachment B: 2.1-3.9mm
BYJ-II 1101 (BJ1301) Sagittal saw
BYJZ-I 21 (BJ2103B) Cannulated drill attachment
BYJZ-I 52 (BJ5209) Reciprocating saw attachment
BYJZ-I 54 (BJ5403S) Cannulated drill attachment
BYJZ-I 66 (BJ6602) High speed bone drill attachment
BYJZ-I 21 (BJ2101) Sagittal saw attachment
BYJ-II 4106 (BJ4106 ) Reciprocating saw (Sternum saw)
BYJZ-I 54 (BJ5402V) Keyless drill attachment
BYJZ-I 66 (BJ6609) Reciprocating saw attachment
BYZ-II 1103 (BJ1103D) Dual functional cannulated drill
BYZ-II 1107 (BJ1307B ) Acetabulum reaming drill
BYZ-II 4103 (BJ4103D) Dual functional cannulated drill
BYJZ-I 52 (BJ5202SAO) Small AO drill attachment
BYJZ-I 54 (BJ5402D) High-speed drill attachment
BYJZ-I 66 (BJ6607D) Cannulated drill attachment(Large AO coupling)
BYJ-II 1109 (BJ1109) Reciprocating saw
BYJZ-I 52 (BJ5207D) Acetabulum reamer attachment
BYJ-II 8109 (BJ8109) Reciprocating saw
BYJZ-I 66 (BJ6601) Sagittal saw attachment
BYZ-II 1103 (BJ1103) Cannulated drill
BYZ-II 1103 (BJ1303S) Dual functional cannulated drill
BYJZ-I 52 (BJ5201) Sagittal saw attachment
BYJZ-I 54 (BJ5402) High-speed drill attachment
BYJZ-I 84 (BJ8402SAO) Small AO drill attachment
BYJZ-I 66 (BJ6603S) Cannulated drill attachment(Hudson coupling)
BYZ-II 1103 (BJ1103B) Dual functional cannulated drill
BYZ-II 1107 (BJ1307) Acetabulum reaming drill
BYJZ-I 52 (BJ5202) High-speed drill attachment
BYJZ-I 54 (BJ5402B) High-speed drill attachment
BYJZ-I 84 (BJ8413-I) Pin and wire driver attachment
BYJZ-I 66 (BJ6607B) Cannulated drill attachment(Stryker coupling)
BYJ-II 1106 (BJ1106) Reciprocating saw (Sternum saw)
BYZ-II 4103 (BJ4103B) Dual functional cannulated drill
BYZ-II 5102 (BJ5102) High speed bone drill
BYJZ-I 52 (BJ5203D) Cannulated drill attachment
BYJ-II 8101 (BJ8101) Sagittal saw
BYJZ-I 82 (BJ8213A) Pin and wire driver attachment
BYZ-II 3402 (BJ3402-IV) Smart driver
BJ5513A-B Pin and wire driver attachment
BYZ-II 1102 (BJ1102) High speed bone drill
BYZ-II 5107 (BJ5107S) Acetabulum reaming drill
BYJZ-I 56 (BJ5613) Pin and wire driver attachment
BYJZ-I 84 (BJ8413-II) Pin and wire driver attachment
BYZ-II 1103 (BJ1103S) Dual functional cannulated drill
BYJZ-I 21 (BJ2100) Multi-functional Handpiece
BYZ-II 4103 (BJ4103S) Dual functional cannulated drill
BYJZ-I 54 (BJ5402S) High-speed drill attachment
BYJZ-I 66 (BJ6607S) Cannulated drill attachment(Hudson coupling)
BYZ-II 1107 (BJ1107B) Acetabulum reaming drill
BYZ-II 5103 (BJ5103B) Dual functional cannulated drill
BYJZ-I 52 (BJ5203S) Cannulated drill attachment
BYZ-II 8102 (BJ8102) High speed bone drill
BYJZ-I 82 (BJ8213B) Pin and wire driver attachment
BYZ-II 3407 (BJ3407-IV) Screwing driver
BYJZ-I 21 (BJ2109) Reciprocating saw attachment
BYJZ-I 42 (BJ4203D) Cannulated drill attachment
BYJZ-I 54 (BJ5411) Torque limiter attachment
BYZ-II 5507 (BJ5507B) Acetabulum reaming drill
BYJZ-I 84 (BJ8400) Multi-functional Handpiece
BYJZ-I 21 (BJ2102SAO) Small AO drill attachment
BYJZ-I 21 (BJ2113B) Pin and wire driver attachment
BYJ-II 4109 (BJ4109) Reciprocating saw
BYJZ-I 42 (BJ4207S) Acetabulum reamer attachment
BYJZ-I 54 (BJ5403B) Cannulated drill attachment
BYJ-II 5501 (BJ5501) Sagittal saw
BYJZ-I 82 (BJ8200) Multi-functional Handpiece
BYJZ-I 21 (BJ2101S) Sagittal saw attachment
BYZ-II 4107 (BJ4107B) Acetabulum reaming drill
BYJZ-I 54 (BJ5402SAO) Small AO drill attachment
BYJZ-I 54 (BJ5413) Pin and wire driver attachment
BYJZ-I 66 (BJ6613A) Pin and wire driver attachment A: 0.6-2mm
BYZ-II 4103 (BJ4103) Cannulated drill
BYJ-II 5101 (BJ5101S) Sagittal saw
BYJZ-I 52 (BJ5203B) Cannulated drill attachment
BYZ-II 5503 (BJ5503D) Dual functional cannulated drill
BYJZ-I 58 (BJ5813B) Pin and wire driver attachment
BYJZ-I 82 (BJ8209) Reciprocating saw attachment
BYJ-II 3401 (BJ3401-IV) Smart sagittal saw
BYZ-II 4102 (BJ4102) High speed bone drill
BYJZ-I 42 (BJ4201) Sagittal saw attachment
BYJZ-I 42 (BJ4213A) Pin and wire driver attachment
BYZ-II 4102 (BJ4102A) High speed bone drill
BYJ-II 5501 (BJ5501-II) Sagittal saw
BYJZ-I 42 (BJ4201S) Sagittal saw attachment
BYJZ-I 42 (BJ4213B) Pin and wire driver attachment
BYJZ-I 82 (BJ8202) High-speed drill attachment
BYJ-II 5501 (BJ5501S) Sagittal saw
BYJZ-I 58 (BJ5800) Multi-functional Handpiece
BYJZ-I 82 (BJ8202SAO) Small AO drill attachment
BYJ-II 1101 (BJ1101S) Sagittal saw
BYJZ-I 42 (BJ4207D) Acetabulum reamer attachment
BYZ-II 5107 (BJ5107D) Acetabulum reaming drill
BYJZ-I 56 (BJ5600) Multi-functional Handpiece
BYJZ-I 84 (BJ8409) Reciprocating saw attachment
BYZ-II 1102 (BJ1302) High-speed bone drill
BYJZ-I 21 (BJ2103D) Cannulated drill attachment
BYJZ-I 52 (BJ5213A) Pin and wire driver attachment
BYJZ-I 54 (BJ5407) Acetabulum reamer attachment
BYJZ-I 66 (BJ6602SAO) Small AO drill attachment
SGJ-IV-BY1201S (BJ1201S-IV) Plaster cutting saw
BYZ-II 1107 (BJ1107S) Acetabulum reaming drill
BYJZ-I 52 (BJ5207B) Acetabulum reamer attachment
BYZ-II 8103 (BJ8103) Cannulated drill
BYJZ-I 66 (BJ6600) Multi functional handpiece
BYZ-II 1107 (BJ1107D) Acetabulum reaming drill
BYZ-II 5103 (BJ5103D) Dual functional cannulated drill
BYJZ-I 52 (BJ5206) Reciprocating saw attachment (Sternum saw)
BYZ-II 8102 (BJ8102SAO) High speed bone drill
BYJ-II 3409 (BJ3409) Smart reciprocating saw
BYZ-II 1102 (BJ1102A) High speed bone drill
BYJ-II 5109 (BJ5109) Reciprocating saw
BYJZ-I 56 (BJ5613A) Pin and wire driver attachment
BYJZ-I 84 (BJ8401-II) Sagittal saw attachment
BYJZ-I 66 (BJ6603B) Cannulated drill attachment(Stryker coupling)
BYZ-II 4102 (BJ4102SAO) High speed bone drill
BYJ-II 5101 (BJ5101H) Sagittal saw
BYZ-II 5503 (BJ5503B) Dual functional cannulated drill
BYJZ-I 58 (BJ5813A) Pin and wire driver attachment
BYJZ-I 82 (BJ8207) Low speed drill attachment
BYJZ-I 84 (BJ8418) Oscillating saw attachment
BYZ-II 1107 (BJ1307S) Acetabulum reaming drill
BYJZ-I 52 (BJ5207S) Acetabulum reamer attachment
BYJZ-I 54 (BJ5403D) Cannulated drill attachment
BYZ-II 8113 (BJ8113A) Pin and wire driver
BYJZ-I 66 (BJ6601H) Sagittal saw attachment
BYJZ-I 21 (BJ2102B) High-speed drill attachment
BYJZ-I 21 (BJ2113A) Pin and wire driver attachment
BYZ-II 4107 (BJ4107S) Acetabulum reaming drill
BYJZ-I 54 (BJ5403) Cannulated drill attachment
BYJZ-I 54 (BJ5413B) Pin and wire driver attachment
BYZ-II 8113 (BJ8113B) Pin and wire driver
BYZ-II 1103 (BJ1303B ) Dual functional cannulated drill
BYJZ-I 21 (BJ2106) Reciprocating saw attachment (Sternum saw)
BYJZ-I 42 (BJ4202) High-speed drill attachment
BYJZ-I 52 (BJ5213B) Pin and wire driver attachment
BYJZ-I 54 (BJ5407B) Acetabulum reamer attachment
BYJZ-I 21 (BJ2110) Torque limiter attachment
BYJZ-I 42 (BJ4203S) Cannulated drill attachment
BYZ-II 5103 (BJ5103S) Dual functional cannulated drill
BYJZ-I 54 (BJ5411S) Torque limiter attachment
BYZ-II 5507 (BJ5507D) Acetabulum reaming drill
BYJZ-I 84 (BJ8401) Sagittal saw attachment
BYZ-II 1103 (BJ1303D) Dual functional cannulated drill
BYJZ-I 21 (BJ2107) Acetabulum reamer attachment
BYJZ-I 42 (BJ4202A) High-speed drill attachment
BYJZ-I 54 (BJ5407D) Acetabulum reamer attachment
SGJ-III-BY1201 (BJ1201-III) Plaster cutting saw with vacuum cleaner
BYJZ-I 21 (BJ2111) Torque limiter attachment
BYJZ-I 42 (BJ4206) Reciprocating saw attachment (Sternum saw)
BYJ-II 5106 (BJ5106) Reciprocating saw (Sternum saw)
BYZ-II 5507 (BJ5507S) Acetabulum reaming drill
BYJZ-I 84 (BJ8402) High-speed drill attachment
BYJ-II 1101 (BJ1101) Sagittal saw
BYJZ-I 42 (BJ4207B) Acetabulum reamer attachment
BYZ-II 5107 (BJ5107B) Acetabulum reaming drill
BYJ-II 5509 (BJ5509) Reciprocating saw
BYJZ-I 84 (BJ8403) Cannulated drill attachment
BYJZ-I 21 (BJ2107B) Acetabulum reamer attachment
BYJZ-I 42 (BJ4202B) High-speed drill attachment
BYJZ-I 54 (BJ5407S) Acetabulum reamer attachment
BYZ-II 4102 (BJ4102B) High speed bone drill
BYJ-II 5101 (BJ5101) Sagittal saw
BYZ-II 5502 (BJ5502) High speed bone drill
BYJZ-I 58 (BJ5813) Pin and wire driver attachment
BYJZ-I 82 (BJ8203) Cannulated drill attachment
BYJZ-I 21 (BJ2103) Cannulated drill attachment
BYJ-II 4101 (BJ4101) Sagittal saw
BYJZ-I 42 (BJ4200) Multi-functional Handpiece
BYJZ-I 42 (BJ4209) Reciprocating saw attachment
BYJ-II 5501 (BJ5501H) Sagittal saw
BYJZ-I 82 (BJ8201) Sagittal saw attachment
Drill Bit(Non-Sterile)-BJDZJ
Drill Bit(Non-Sterile)-BJ-044-015-001-B
Drill Bit(Sterile)-(S)BJJDR
BJXDH.XZRZ-00
Drill Bit(Non-Sterile)-BJJDY
Drill Bit(Non-Sterile)-BJRGK
Drill Bit(Non-Sterile)-BJ-000-003-001
FLEXIBLE REAMER
Drill Bit(Sterile)-(S)BJXW
Drill Bit(Sterile)-(S)BJJDY
Drill Bit(Sterile)-(S)BJRGK
Drill Bit(Sterile)-(S)BJ340210
Drill Bit(Sterile)-(S)BJXZ
Drill Bit(Non-Sterile)-BJZT
Drill Bit(Sterile)-(S)BJDZZ
Drill Bit(Sterile)-(S)BJXXZ
Drill Bit(Sterile)-(S)BJ-000-003-001
Drill Bit(Sterile)-(S)BJZC
Drill Bit(Non-Sterile)-BJXW
Drill Bit(Non-Sterile)-BJDZG
Drill Bit(Non-Sterile)-BJ340210
Drill Bit(Non-Sterile)-BJ1107S1T
Drill Bit(Non-Sterile)-BJDZL
Drill Bit(Non-Sterile)-BJ-044-015-001-D
Drill Bit(Non-Sterile)-BJDZP
Drill Bit(Non-Sterile)-BJ-044-015-001-S
Drill Bit(Non-Sterile)-BJZCZ
Drill Bit(Sterile)-(S)BJDZP
Drill Bit(Sterile)-(S)BJDZG
Drill Bit(Sterile)-(S)BJZT
Drill Bit(Sterile)-(S)BJDZ
Drill Bit(Sterile)-(S)BJZCZ
Drill Bit(Sterile)-(S)BJJDDT
Drill Bit(Non-Sterile)-BJ1107B1T
Drill Bit(Non-Sterile)-BJDZ
Drill Bit(Non-Sterile)-BJXXZ
Drill Bit(Non-Sterile)-BJJDDT
Drill Bit(Non-Sterile)-BJXZ
Drill Bit(Sterile)-(S)BJDZJ
Drill Bit(Non-Sterile)-BJZC
Drill Bit(Sterile)-(S)BJDZL
Drill Bit(Non-Sterile)-BJJDR
Drill Bit(Non-Sterile)-BJDZZ
Drill Bit(Non-Sterile)-BJ1107D1T
Establishment Types
Manufacture Medical Device