Identity
- Trade Name
- Tape Patch EUDAMED
- Device Name
- Tape Patch EUDAMED
- Model / Reference
- ATTPE-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800069700154 EUDAMED
- Basic UDI-DI
- 88000697TapePatchHH EUDAMED
- EMDN Code
- Z12050485 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Tape Patch by ATsens.co., Ltd. — 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 | 88000697TapePatchHH | Class I | Active |
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Manufacturer
- Manufacturer
- ATsens Co., Ltd.
- EUDAMED SRN
- KR-MF-000017532
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 9dda03ad-7b11-40d3-bf6a-a9eec20c4820 61 fields · synced Jul 30, 2026