Rapid Biomedical GmbH
RIMPAR Bavaria, DE
RAPID BIOMEDICAL GMBH appears in FDA device records in RIMPAR Bavaria, DE. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Rapid Biomedical GmbH between 2008 and 2023. The busiest year on record is 2018, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil | MOS | Substantially Equivalent | |
| K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | MOS | Substantially Equivalent | |
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | MOS | Substantially Equivalent | |
| K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil | MOS | Substantially Equivalent | |
| K102748 | 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T | MOS | Substantially Equivalent | |
| K102348 | 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T | MOS | Substantially Equivalent | |
| K083255 | 16CH AI BREAST COILS 1.5 T AND 3 T | MOS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005049692 | 3005049692 | RAPID BIOMEDICAL GMBH | KETTELERSTR. 3-11, RIMPAR Bavaria 97222 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain