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SANDSTONE MEDICAL (SUZHOU) INC.

China·CN-MF-000011105

Last updated September 17, 2026

Information

Country: China
Address: 168, PuTuoShan, Suzhou, China
Website: sandstonemed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Juanjuan Sun
EUDAMED SRN: CN-MF-000011105
FDA FEI Number: 3015955792
DUNS Number: —

Catalogue (54)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Safety Pen Needles	05-3105	EUDAMED	Class IIa	Active
Safety Pen Needles	GD103698	EUDAMED	Class IIa	Active
Safety Pen Needles	06-3005	EUDAMED	Class IIa	Active
Easydrip Readygard Duo	05-3105	EUDAMED	Class IIa	Active
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle	K252908	FDA 510(k)	Class II	Active
Pen Needles	01-3105	EUDAMED	Class IIa	Active
Safety Pen Needles	06-3108	EUDAMED	Class IIa	Active
Pen Needles	AP29G12	EUDAMED	Class IIa	Active
Pen Needles	01-3204 32G×4mm	EUDAMED	Class IIa	Active
Apwell	02-3106	EUDAMED	Class IIa	Active
Pen Needles	01-3206	EUDAMED	Class IIa	Active
Easydrip Pen Needles	01-3208	EUDAMED	Class IIa	Active
Medhave Pen Needles	01-3204	EUDAMED	Class IIa	Active
Safety Pen Needles	SPN3008D	EUDAMED	Class IIa	Active
Vitrex	531113 30G×5mm	EUDAMED	Class IIa	Active
Easydrip Pen Needles	04-3106	EUDAMED	Class IIa	Active
Safety Pen Needles	03-3106	EUDAMED	Class IIa	Active
Easydrip	01-3204 32×4mm	EUDAMED	Class IIa	Active
Easydrip Pen Needles	01-3106	EUDAMED	Class IIa	Active
Easydrip Pen Needles	04-3204	EUDAMED	Class IIa	Active
Pen Needles	HAR3204 32G×4mm	EUDAMED	Class IIa	Active
Easydrip Pen Needles	01-29127	EUDAMED	Class IIa	Active
Easydrip	01-2912	EUDAMED	Class IIa	Active
Contour comfort	04-3204	EUDAMED	Class IIa	Active
Safety Pen Needles	SPN3108D	EUDAMED	Class IIa	Active
Safety Pen Needles	03-3108	EUDAMED	Class IIa	Active
Safety Pen Needles	05-2908	EUDAMED	Class IIa	Active
Easydrip Pen Needles	03-3205	EUDAMED	Class IIa	Active
Easydrip	01-3204	EUDAMED	Class IIa	Active
Pen Needles	IPN-32-5	EUDAMED	Class IIa	Active
Pen Needles	I23204	EUDAMED	Class IIa	Active
Easydrip Pen Needles	04-3205	EUDAMED	Class IIa	Active
Safety Pen Needles	05-3005	EUDAMED	Class IIa	Active
Pen Needles	01-3106	EUDAMED	Class IIa	Active
Easydrip	01-3105	EUDAMED	Class IIa	Active
Contour comfort	04-3204	EUDAMED	Class IIa	Active
Easydrip Pen Needles	02-3206	EUDAMED	Class IIa	Active
Safety Pen Needles	SPN3206D	EUDAMED	Class IIa	Active
Contour comfort	04-3106	EUDAMED	Class IIa	Active
Easydrip Pen Needles	01-3108	EUDAMED	Class IIa	Active
Pen Needles	AP32G04	EUDAMED	Class IIa	Active
Safety Pen Needles	06-3204	EUDAMED	Class IIa	Active
Pen Needles	01-3204	EUDAMED	Class IIa	Active
Easydrip Pen Needles	04-3105	EUDAMED	Class IIa	Active
Harmofine	HAR2912	EUDAMED	Class IIa	Active
Pen Needles	3204	EUDAMED	Class IIa	Active
Pen Needles	02-3106	EUDAMED	Class IIa	Active
Easydrip	01-3106	EUDAMED	Class IIa	Active
Dual Safety Pen Needles	GD103699 31G×5mm	EUDAMED	Class IIa	Active
Pen Needles	02-3108	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Sandstone Medical (Suzhou) Inc. US