Identity
- Trade Name
- ZILOS-tk® Biopsy EUDAMED
- Device Name
- HT Laser Biopsy EUDAMED
- Model / Reference
- ZILOS-tk Biopsy EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858604006030 EUDAMED
- Basic UDI-DI
- 0858604006LASER3E EUDAMED
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
ZILOS-tk® Biopsy by Hamilton Thorne, Inc — 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 | 0858604006LASER3E | Class I | Active |
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Manufacturer
- Manufacturer
- Hamilton Thorne, Inc
- EUDAMED SRN
- US-MF-000016539
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED f67c5fc5-e2f7-4d5c-bd61-a927eccf389f 61 fields · synced Jun 20, 2026