Identity
- Trade Name
- Glooko XT EUDAMED
- Device Name
- Glooko XT Patient EUDAMEDGlooko XT Pro EUDAMED
- Model / Reference
- REF-0010 EUDAMEDREF-0009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00855093008095 EUDAMED00855093008101 EUDAMED
- Basic UDI-DI
- 0085509300REF-0010UR EUDAMED0085509300REF-0009V8 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Glooko XT by Glooko, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0085509300REF-0010UR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Glooko, Inc.
- EUDAMED SRN
- US-MF-000023483
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 58edee9a-06c5-4ce6-b239-8299fffd8d25 61 fields · synced Jul 31, 2026
- EUDAMED 5e628961-c0bf-4ffb-8f45-4bb56eb9e7e2 61 fields · synced May 18, 2026