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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 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Custom Medical Specialties, Inc. | CMS-155 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-610 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-5206 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4506-R6 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4144-R5 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-108 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-655 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-8520-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-950V | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-954P | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-6299 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1622 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-999-CX | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1637-NS | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-200-2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-955V | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-1996-2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-7190 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4624-R6 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-171 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-117 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-5608-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-2891-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-706 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-6033 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-5896 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-4153-R3 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4224 | FDA UDI | N/A | Active |
| Custom Medical Specialties, Inc. | CMS-5931 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1270 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-5750-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-6415-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-2357-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-3628BB-NS | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-1236 | FDA UDI | Class II | Active |
| Mpm | MM-299 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-4028-R5 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-950V-8 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-6671-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-999-XL | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-8379-R2 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-958V | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-905V-8 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-4364-R6 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-955P-6 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-6454-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-706-NS | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-6601-R1 | FDA UDI | Class II | Active |
| Custom Medical Specialties, Inc. | CMS-945 | FDA UDI | Class I | Active |
| Custom Medical Specialties, Inc. | CMS-4846-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. |