Identity
- Trade Name
- Kryo360-3.3 EUDAMED
- Device Name
- Kryo560 16 Litre Controlled Rate Freezer EUDAMED
- Model / Reference
- Kryo560 EUDAMEDKryo360-3.3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B199GDKRYO36033M2300 EUDAMED
- Basic UDI-DI
- ++B199KRYOGC EUDAMED
- Direct Marketing DI
- B199GDKRYO36033M2300 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
Kryo360-3.3 by Planer Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Planer Limited
- EUDAMED SRN
- GB-MF-000002773
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED a0135cf4-93cd-4519-ba67-473294d7d5fa 61 fields · synced Jun 18, 2026
- EUDAMED 5ee087c0-5afa-412d-be07-ff2b2f180702 61 fields · synced Jun 18, 2026