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PRIMED MEDICAL PRODUCTS INC.

Canada·CA-MF-000014307

Last updated September 17, 2026

Information

Country: Canada
Address: 200, 2003-91 St SW, Edmonton, AB, Canada, Edmonton, Canada
Website: www.primed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1.780.784.2255
PRRC Contact: Kam Ching
EUDAMED SRN: CA-MF-000014307
FDA FEI Number: 3002750002
DUNS Number: —

Catalogue (188)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Primed	PG4-1692	FDA UDI	Class II	Active
Primed	PG4-1670	FDA UDI	Class II	Active
Primed	PG4-1342	FDA UDI	Class II	Active
Primed	PG4-1472	FDA UDI	Class II	Active
Primed	PG4-1083	FDA UDI	Class II	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-2332E	EUDAMED	Class I	Active
PRIMED Mask (Other Accessories)	PG4-5063E	EUDAMED	Class I	Active
PRIMED Pediatric Facemask	K213427	FDA 510(k)	Class II	Active
Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks	K081633	FDA 510(k)	Class II	Active
Primagard Delta Fit 80, 120, 160 Surgical Face Mask (small, Medium, Large) Model Pg4-7061, -7071, -7081, Pg4-7062, 7072-70	K092012	FDA 510(k)	Class II	Active
PRIMED Surgical and Procedure Masks	K252964	FDA 510(k)	Class II	Active
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)	K160361	FDA 510(k)	Class II	Active
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)	K233777	FDA 510(k)	Class II	Active
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)	K242208	FDA 510(k)	Class II	Active
PRIMED Surgical Masks and PRIMED Procedure Masks	K240286	FDA 510(k)	Class II	Active
PRIMED Mask (Other Accessories)	PG4-2592E	EUDAMED	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-3332E	EUDAMED	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-2073E	EUDAMED	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-2331E	EUDAMED	Class I	Active
PRIMED Gown	PM4-47370	EUDAMEDFDA UDI	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-2333E	EUDAMED	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-1273E	EUDAMED	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-1211E	EUDAMED	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-1001E	EUDAMED	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-4021E	EUDAMED	Class I	Active
PRIMED Gown	PM4-88335	EUDAMEDFDA UDI	Class I	Active
PRIMED Gown	PM4-57372C	EUDAMEDFDA UDI	Class I	Active
PRIMED Gown	PM4-67194	EUDAMEDFDA UDI	Class I	Active
PRIMED Gown	PM4-27370	EUDAMEDFDA UDI	Class I	Active
PRIMED Gown	PM4-67364	EUDAMEDFDA UDI	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-4241E	EUDAMED	Class I	Active
PRIMED Gown	PM4-57162	EUDAMEDFDA UDI	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-2321E	EUDAMED	Class I	Active
PRIMED Gown	PM4-57162XL	EUDAMEDFDA UDI	Class I	Active
PRIMED Mask (Medical, Type II , and IIR)	PG4-4331E	EUDAMED	Class I	Active
PRIMED Mask (Other Accessories)	PG4-1563E	EUDAMED	Class I	Active
PRIMED Gown	PM4-57162XXL	EUDAMEDFDA UDI	Class I	Active
PRIMED Mask (Other Accessories)	PG4-5033E	EUDAMED	Class I	Active

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Authorised Representatives

mdi Europa GmbH DE
mdi Europa GmbH DE

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