Identity
- Trade Name
- PI standard, size 85A, natural EUDAMED
- Device Name
- _/PI standard EUDAMED
- Model / Reference
- LIPO-PI05V00X-N-85A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591846105117 EUDAMED
- Basic UDI-DI
- 8591846PI05V00X-0AZM EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Category: Compression/pressure sock/stocking, reusable
PI standard, size 85A, natural by LIPOELASTIC a.s. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8591846PI05V00X-0AZM | Class I | Active |
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Manufacturer
- Manufacturer
- LIPOELASTIC a.s.
- EUDAMED SRN
- CZ-MF-000002396
Sources (1)
- EUDAMED 5736482b-780b-4963-a739-fea56f2d6178 61 fields · synced Aug 1, 2026