Well Lead Medical Co.,Ltd

Address:C-4 JINHU INDUSTRIAL ESTATE,GUANGZHOU Guangdong,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cystoscope And Accessories, Flexible/Rigid (FAJ) (5) Endoscopic Access Overtube, Gastroenterology-Urology (FED) (5) Kit, Nephroscope (FGA) (5) Tube, Tracheal (W/Wo Connector) (BTR) (3) Endoscope Channel Accessory (ODC) (2)

Premarket Exempt

No Yes

Clear

ClearPetra - 06944932748477 Catalog Number :

Device Description : ClearPetra Nephrostomy Sheath, 26Fr×15cm

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : FED, FAJ, FGA

Prescription Use : Yes

Device Count : 1

ClearPetra - 06944932748484 Catalog Number :

Device Description : ClearPetra Nephrostomy Sheath, 24Fr×17cm

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : FED, FAJ, FGA

Prescription Use : Yes

Device Count : 1

ClearPetra - 06944932748491 Catalog Number :

Device Description : ClearPetra Nephrostomy Sheath, 26Fr×17cm

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : FED, FAJ, FGA

Prescription Use : Yes

Device Count : 1

ClearPetra - 06944932748507 Catalog Number :

Device Description : ClearPetra Nephrostomy Sheath, 24Fr×21cm

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : FED, FAJ, FGA

Prescription Use : Yes

Device Count : 1

ClearPetra - 06944932748514 Catalog Number :

Device Description : ClearPetra Nephrostomy Sheath, 26Fr×21cm

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : FED, FAJ, FGA

Prescription Use : Yes

Device Count : 1

Nasal Jet Tube - 06944932776227 Catalog Number :

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Nasal Jet Tube - 06944932776241 Catalog Number :

Device Description : 26Fr

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Nasal Jet Tube - 06944932776265 Catalog Number :

Device Description : 30Fr

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Wellead - 06944932785113 Catalog Number :

Device Description : Endoscopic Seal, Type I

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

Wellead - 06944932785120 Catalog Number :

Device Description : Endoscopic Seal, Type I (adapter)

Device Class :

Duns Number: 544811862

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

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