Is this your brand? Sign in to claim ownership.

CUSTOM ASSEMBLIES, INC.

Last updated September 17, 2026

Information

Country: US
Address: 330 EAST MAIN STREET, PINE LEVEL, NC, 27568
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3000718854
DUNS Number: —

Catalogue (336)

Page 2 of 7

Device	Model / Reference	Registries	Class	Status
Custom Medical Specialties, Inc.	CMS-5127-R7	FDA UDI	N/A	Active
Pg-1000	PG-1000	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-5901-R1	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1235	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-4917-R3	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-3628BB	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1214	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-104	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-6314-R6	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-6674-R3	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-5109-R3	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-3030BB-NS	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-951V	FDA UDI	Class I	Active
Mpm	BMTX-1027-R1	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-660	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-4501-R5	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1203	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-4537-R2	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-5368-R2	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-851	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-586	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-608	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-4912-B	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-4675-R3	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1250	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1228-NS	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1212	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-225-2	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1333-20-LS	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-909-8	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-905V-6	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-702	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-6637-R1	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-0512-BBNS	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1701	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-6390-R5B	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-4623-R2	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-955P-10	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-7152-R1	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-2981-R6	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-954P-6	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-999-6	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-6025	FDA UDI	Class I	Active
Custom Medical Specialties, Inc.	CMS-4434-R1	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-3630BB	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1212-NS	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-170	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-1245	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-6397	FDA UDI	Class II	Active
Custom Medical Specialties, Inc.	CMS-4112-R2	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 15, 2017	Z-3059-2017	—	terminated	The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.