Identity
- Trade Name
- CT37stax EUDAMEDCT37 Incubator FDA UDI
- Generic Name
- Assisted reproduction heater/incubator FDA UDI
- Device Name
- CT37stax Benchtop Incubator EUDAMEDCT37Stax Incubator FDA UDI
- Model / Reference
- CT37stax EUDAMEDGDCT37-M EUDAMEDFDA UDIGDCT37-M-6 FDA UDI
- Description
- CT37Stax Incubator FDA UDI
Identifiers
- Primary DI / UDI-DI
- B199GDCT37M60 EUDAMEDFDA UDIB199GDCT37M0 FDA UDI
- Basic UDI-DI
- B-B199GDCT37M60 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
- Romania 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 vitrification carrier
CT37stax by Planer Limited — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-B199GDCT37M60 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Planer Limited
- EUDAMED SRN
- GB-MF-000002773
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 62d93ca3-5f6a-43c3-8036-fd10bdbef7d3 61 fields · synced Jul 10, 2026
- FDA UDI 17bee430-1ddd-4c84-aacd-f4682d366261 34 fields · synced May 29, 2026
- FDA UDI 31091919-6485-4da1-9303-f1ba082df34c 34 fields · synced May 30, 2026