Identity
- Trade Name
- TC,MAMMO,SMS,185X90/60 EUDAMED
- Device Name
- Medical Drapes, Medical Gowns and Medical Equipment Covers, to be sterilised before use EUDAMED
- Model / Reference
- 1307249 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08710685116973 EUDAMED
- Basic UDI-DI
- 8710685TF05001002QX EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Tc, Mammo, Sms, 185x90/60 by Medica Europe B.V. — 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 | 8710685TF05001002QX | Class I | Active |
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Manufacturer
- Manufacturer
- Medica Europe B.V.
- EUDAMED SRN
- NL-MF-000000118
Sources (1)
- EUDAMED a9ed6a8a-abfe-49cc-8e7b-b9760f0ff354 61 fields · synced Jun 18, 2026