Identity
- Trade Name
- PHARCO GOWN EUDAMED
- Device Name
- Standard Surgical Gown EUDAMED
- Model / Reference
- 6118002172497 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06118002172497 EUDAMED
- Basic UDI-DI
- 611800217PGSS7K EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Pharco Gown by Pharcomedic — 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 | 611800217PGSS7K | Class I | Active |
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Manufacturer
- Manufacturer
- Pharcomedic
- EUDAMED SRN
- MA-MF-000035738
- Authorised Representative
- S4M EUROPE FR-AR-000000180
Sources (1)
- EUDAMED b7740231-7e1a-47c7-80ab-a32ce76cde37 61 fields · synced Jun 19, 2026