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Sign in to claim this brandCUSTOM ASSEMBLIES, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 330 EAST MAIN STREET, PINE LEVEL, NC, 27568
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3000718854
- DUNS Number
- —
Catalogue (336)
Page 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Custom Medical Specialties, Inc. | CMS-001 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4811 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-12-LL | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4507 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-999-10 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1211-NS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1914 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-5630 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-954V | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-6149-R3 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-5680-R3 | FDA UDI | Class II | Active |
| Custom Medical Specialties | CMS-963 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-851 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6592-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-3191 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-904P | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-2374-R8 | FDA UDI | N/A | Active |
| Custom Medical Specialties, Inc. | CMS-6803-R1 | FDA UDI | Class II | Active |
| Mpm | MPM-312-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1596-36-NS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6479-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-7150 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1202 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1216 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1838-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-8659-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-8114 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-3123-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-18-EC | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-904V | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1105 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4425-R6 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4845-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1219 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | ERRORCMS-155 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-235-2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1222 | FDA UDI | Class II | Unknown |
| Custom Medical Specialties, Inc. | CMS-20-LS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1515BB-NS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6673-R3 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-3141-R6 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1228 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1890-R9 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-969P | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1828 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-3167-R3 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-106 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-151 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-943 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-2540-R4 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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. |