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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 5 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Custom Medical Specialties, Inc. | CMS-5489-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6314-R5 | FDA UDI | Class II | Unknown |
| Custom Medical Specialties, Inc. | CMS-955V-6 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1794-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-0082 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-954P-8 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1980-R3 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-3036BB-NS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1113 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-2930-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6481 | FDA UDI | Class II | Active |
| Custom Assemblies, Inc. | CMS-2012-R3 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-7040-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6688 | FDA UDI | Class II | Active |
| Mpm | BMTX-1024 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6540-R4 | FDA UDI | N/A | Active |
| Custom Medical Specialties, Inc. | CMS-1219-NS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-8145 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-248 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-950P | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-900P | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-8522-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1214-NS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4670-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-905V | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-4647-R3 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6025-NS | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-985V | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1993-2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-631-SC | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-6976-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1211 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-606 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-2123-R4 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-3169-R5 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-609 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-2576-R5 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-955V-8 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-515 | FDA UDI | Class I | Active |
| Custom Medical Specialties | CMS-6013 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-2015BB | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-8240 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-5922-R2 | FDA UDI | Class II | Active |
| Mpm | BMTX-1029 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1218 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1201 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6408 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-21GA | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-951V-6 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1216-NS | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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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. |