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| Tily Blooms | Unregulated kits | Regulated but imported | |
|---|---|---|---|
| MHRA registered medical device | ✓ | ✕ | ✓ |
| UK manufactured | ✓ UK | ✕ Often China | ✕ Often China |
| No UK Responsible Person needed | ✓ Direct | — No regulation | ⚠ 3rd-party |
| Direct MHRA accountability | ✓ Direct | ✕ None | ⚠ Via intermediary |
| Full UK supply chain | ✓ | ✕ | ✓ |
| Single-use collection cup | ✓ Certified | ✕ Often reusable | ✓ |
| Single-use insemination device | ✓ Certified | ✕ Often 3–4 included | ✓ |
| Purpose-designed components | ✓ Every item | ✕ Often repurposed | ✓ |
| ISO 13485 certified manufacturing | ✓ | ✕ | ✓ |
| UKCA marked | ✓ | ✕ | ✕ |
| Calm, detailed guidebook | ✓ Founder-written | ✕ Varies | ✓ |
| Founded from lived experience | ✓ Solo mum by choice | ✕ | ✕ |
| Affordable UK pricing | ✓ | ⚠ Often cheaper | ✕ Often more expensive |
| Competitor information is based on publicly available product listings. Tily Blooms does not make claims about specific competitor products by name. If in doubt, always check whether a kit is listed on the MHRA medical device register before purchasing at mhra.gov.uk. | |||
You might see cheaper kits that include 3 or 4 syringes and only 1 collection cup to be reused. It can look like better value. But it’s worth understanding what that actually means.
As a regulated Class 1 medical device, Tily Blooms components are certified for single use only. This is not a cost decision - it is a safety and regulatory requirement. Reusing a collection cup or insemination device at home carries contamination risk and can affect the viability of the sample. A regulated kit cannot legally include components intended to be reused.
When you see a cheaper kit with multiple syringes and one collection cup, ask whether it is registered as a medical device with the MHRA and if they have a cleaning validation study. If it isn’t, there is no requirement for it to answer that question.