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Bt37
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GDBT37-02-WW-CSModel BT37Ref GDBT37-01-ORIGIO
Identity
- Trade Name
- BT37 EUDAMEDFDA UDIBT37 Incubator FDA UDI
- Generic Name
- Assisted reproduction heater/incubator FDA UDIAssisted reproduction freezer FDA UDI
- Device Name
- BT37 Benchtop Incubator EUDAMEDBT37 Unit Origio EUDAMEDBT37 Benchtop Incubator - Origio FDA UDIBT37 Mark 2, Benchtop Incubator. Worldwide FDA UDI
- Model / Reference
- BT37 EUDAMEDGDBT37-02-WW-CS EUDAMEDGDBT37-01-ORIGIO EUDAMEDFDA UDIBT37-02 FDA UDI
- Description
- BT37 Benchtop Incubator - Origio FDA UDIBT37 Mark 2, Benchtop Incubator. Worldwide FDA UDI
Identifiers
- Catalog Number
- GDBT37-02-WW-CS FDA UDI
- Primary DI / UDI-DI
- B199GDBT3702WWCS0 EUDAMEDFDA UDIB199GDBT3701ORIGIO0 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B199GDBT3702WWCS0 EUDAMEDB-B199GDBT3701ORIGIO0 EUDAMED
- 510(k) Number
- K121566 FDA UDI
- FDA Product Code
- MQG FDA UDIPUB FDA UDI
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
- GMDN Term
- Assisted reproduction heater/incubator FDA UDIAssisted reproduction freezer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Market of Registration
- Denmark EUDAMEDNetherlands 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
Yes
FDA UDIFDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDIFDA 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
Bt37 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-B199GDBT3702WWCS0 | 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 (4)
- EUDAMED 942674d2-b6d2-47ff-83e5-0a9c52feb9d7 61 fields · synced Sep 17, 2026
- FDA UDI aaf217e0-2db5-47f2-b1c1-879f03651d57 35 fields · synced May 29, 2026
- FDA UDI a8e5c987-6551-4a3a-ba89-fd4898196084 34 fields · synced May 30, 2026
- EUDAMED 42b99c34-0cae-45e3-9a04-98a36c554bf0 61 fields · synced Sep 17, 2026