Identity
- Trade Name
- Glandy EUDAMED
- Device Name
- Glandy EUDAMED
- Model / Reference
- Glandy HYPER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947150050 EUDAMED
- Basic UDI-DI
- 880994715001HYPER0000G5 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
- Germany 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
Glandy by Thyroscope 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 | 880994715001HYPER0000G5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Thyroscope Inc.
- EUDAMED SRN
- KR-MF-000045350
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 3e20d96b-5671-4e40-98c8-f9c6d98b498c 61 fields · synced Jun 19, 2026