Identity
- Trade Name
- Twoplus Applicator Extra EUDAMED
- Device Name
- Home-use Artificial Insemination Kit EUDAMED
- Model / Reference
- HC03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08881300389048 EUDAMED
- Basic UDI-DI
- 8881300389HC036K EUDAMED
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Assisted reproduction vitrification carrier
Twoplus Applicator Extra by Hannah Life Technologies Pte Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8881300389HC036K | Class I | Active |
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Manufacturer
- Manufacturer
- Hannah Life Technologies Pte Ltd
- EUDAMED SRN
- SG-MF-000052466
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED 490fefe7-a7e6-4992-86f8-32f81a61e2d1 61 fields · synced Jul 18, 2026