Identity
- Trade Name
- Kryo 560 Freezer FDA UDI
- Generic Name
- Freezer control unit, programmable FDA UDI
- Device Name
- Kryo 560 Controlled Rate Freezer. 16 Litre Chamber FDA UDI
- Model / Reference
- GDKRYO560-16-115-DT FDA UDI
- Description
- Kryo 560 Controlled Rate Freezer. 16 Litre Chamber FDA UDI
Identifiers
- Primary DI / UDI-DI
- B199GDKRYO56016155DT0 FDA UDI
- FDA Product Code
- KSP FDA UDI
- GMDN Term
- Freezer control unit, programmable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9225 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assisted reproduction freezerFreezer control unit, programmable
Kryo 560 Freezer by Planer Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Freezer control unit, programmable.
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- Kryo 360 Freezer — Planer Plc · Class I
- Kryo 750 Freezer - Front Loader — Planer Plc · Class I
- MRV Contoller — Planer Plc · Class I
- Kryo — Planer Plc · Class I
- MRV Controller Adaptor — PLANER LIMITED · Class I
- Kryo 360 Freezer — PLANER LIMITED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Planer Limited
Sources (2)
- FDA UDI 5e85aa7e-a122-457f-a623-dbca7dc5cbfa 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026