Identity
- Trade Name
- Glandy EUDAMED
- Device Name
- Glandy EUDAMED
- Model / Reference
- Glandy LID EUDAMEDGlandy CAS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947150043 EUDAMED08809947150012 EUDAMED
- Basic UDI-DI
- 880994715000LID0000QT EUDAMED880994715000CAS0000MX EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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 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 | 880994715000LID0000QT | Class I | Active |
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Manufacturer
- Manufacturer
- Thyroscope Inc.
- EUDAMED SRN
- KR-MF-000045350
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 484527dc-3192-4b0e-b37b-38db6a4713dd 61 fields · synced Aug 1, 2026
- EUDAMED 5d673c3a-c984-4bcc-a834-976d1f168105 61 fields · synced May 18, 2026