Identity
- Trade Name
- Kryo360-1.7 EUDAMED
- Device Name
- Kryo560 16 Litre Controlled Rate Freezer EUDAMED
- Model / Reference
- Kryo560 EUDAMEDKryo360-1.7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B199GDKRYO36017M2300 EUDAMED
- Basic UDI-DI
- ++B199KRYOGC EUDAMED
- Direct Marketing DI
- B199GDKRYO36017M2300 EUDAMED
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Kryo360-1.7 by Planer Limited — 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 | ++B199KRYOGC | Class I | Active |
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Manufacturer
- Manufacturer
- Planer Limited
- EUDAMED SRN
- GB-MF-000002773
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED eb562305-4a6b-4e80-bfef-745471c564d8 61 fields · synced Jul 11, 2026