Identity
- Trade Name
- MONOCLEAN TYPE 19B EUDAMED
- Device Name
- MONOCLEAN TYPE 19B EUDAMED
- Model / Reference
- MONO 19B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056254790084 EUDAMED
- Basic UDI-DI
- 805625479TAMP_ORALE2P EUDAMED
- Direct Marketing DI
- 08056254790084 EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Monoclean Type 19b by Pharma Eec Srl — 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 | 805625479TAMP_ORALE2P | Class I | Active |
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Manufacturer
- Manufacturer
- Pharma Eec Srl
- EUDAMED SRN
- IT-MF-000037561
Sources (1)
- EUDAMED dfc4c8a2-6b93-498f-86bd-0f171a24f811 61 fields · synced Jun 19, 2026