Identity
- Trade Name
- Glooko Transmitter EUDAMED
- Model / Reference
- REF-0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00855093008057 EUDAMED
- Basic UDI-DI
- 0085509300TransRef003SQ EUDAMED
- Direct Marketing DI
- 00855093008057 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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 Transmitter by Glooko, Inc. — Class I — 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 | 0085509300TransRef003SQ | Class I | Active |
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Manufacturer
- Manufacturer
- Glooko, Inc.
- EUDAMED SRN
- US-MF-000023483
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 17af5e4b-4f6d-42f3-8017-cea794769e42 61 fields · synced Jun 19, 2026