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| Brand | Barkey |
|---|---|
| Origin | United Kingdom |
| Model | Barkey Plasmatherm |
| Instrument Type | Dry-phase (non-contact, closed-loop thermal transfer) thawing system |
| Regulatory Classification | Class II medical device per MDR 2017/745 (EU), compliant with ISO 23500-1:2023 for blood component warming |
| Software Compliance | Audit-trail enabled, 21 CFR Part 11–ready data logging |
| Certification | CE-marked, UKCA-certified, GMP-aligned design |
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