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CT37 Incubator
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref GDCT37-M-5 Ref GDCT37-M-3
by Planer Plc
Identity
- Trade Name
- CT37 EUDAMEDCT37 Incubator FDA UDI
- Generic Name
- Assisted reproduction heater/incubator FDA UDI
- Device Name
- CT37 EUDAMEDCT37 Base Unit with 3 slots and chambers EUDAMEDCT37Stax Incubator FDA UDI
- Model / Reference
- GDCT37-M-3 EUDAMEDFDA UDIGDCT37-M-5 EUDAMEDFDA UDI
- Description
- CT37Stax Incubator FDA UDI
Identifiers
- Primary DI / UDI-DI
- B199GDCT37M30 EUDAMEDFDA UDIB199GDCT37M50 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B199GDCT37M50 EUDAMEDB-B199GDCT37M30 EUDAMED
- FDA Product Code
- PUB FDA UDI
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
- GMDN Term
- Assisted reproduction heater/incubator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 heater/incubator
CT37 Incubator by Planer Plc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Planer Plc
Sources (4)
- FDA UDI 763bb96f-302f-46f5-aff7-f0f1119d9eec 34 fields · synced Jul 19, 2026
- FDA UDI f6f6169a-fe4c-4b07-b37f-bc044ac12957 34 fields · synced May 30, 2026
- EUDAMED f48398a7-820a-4442-a344-55c986486d06 61 fields · synced Jul 18, 2026
- EUDAMED 6bc3b2d9-0a19-4f24-b142-f4fa543e6757 61 fields · synced Jul 19, 2026