Identity
- Trade Name
- Kryo560 EUDAMED
- Device Name
- Kryo560 16 Litre Controlled Rate Freezer EUDAMED
- Model / Reference
- Kryo560 EUDAMEDGDKRYO560-16-M-230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B199GDKRYO56016M2300 EUDAMED
- Basic UDI-DI
- ++B199KRYOGC EUDAMED
- Direct Marketing DI
- B199GDKRYO56016M2300 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
Kryo560 by Planer Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Assisted reproduction vitrification carrier.
- S-CRYOLOCK (B) — BIOTECH INCORPORATED · Class II
- VitriGuard — Origio A/S · Class II
- Serological Pipette 1 mL — BIRR Biosciences BV · Class IIa
- Dry Incubator / EC6S-230MR — ASTEC CO.,Ltd · Class IIa
- CRYOPETTE — ORIGIO INC. · Class II
- VitriGuard — Origio A/S · Class II
- CRYOPETTE — ORIGIO INC. · Class II
- S-CRYOLOCK (G) — BIOTECH INCORPORATED · Class II
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 699dffdb-4c2b-4dc7-a023-89696bcbe809 61 fields · synced Jul 21, 2026
- EUDAMED 6ff69033-5268-4313-9810-817bbb853e19 61 fields · synced Jul 21, 2026