Identity
- Trade Name
- Foliodress® Suit Protect EUDAMED
- Device Name
- Scrub suits with rounded collar EUDAMED
- Model / Reference
- 1271 EUDAMED992552 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04052199160757 EUDAMED
- Basic UDI-DI
- 32614812714H EUDAMED
- Direct Marketing DI
- 04052199160757 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Foliodress® Suit Protect by Laboratoires PAUL HARTMANN S.à.r.l — 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 | 32614812714H | Class I | Active |
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Manufacturer
- Manufacturer
- Laboratoires PAUL HARTMANN S.à.r.l
- EUDAMED SRN
- FR-MF-000004029
Sources (1)
- EUDAMED 0f2b8215-8772-4e24-91c1-87545c1a78c0 61 fields · synced Jun 19, 2026