Identity
- Trade Name
- Proctolyn Natura EUDAMED
- Device Name
- Rectal Gel EUDAMED
- Model / Reference
- PR01 EUDAMED61900402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990632220 EUDAMED
- Basic UDI-DI
- 805299063PROCTO001UW EUDAMED
- EMDN Code
- G99 GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
Proctolyn Natura by Nirial Pharma srl — Class IIb — 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 | 805299063PROCTO001UW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nirial Pharma srl
- EUDAMED SRN
- IT-MF-000018760
Sources (1)
- EUDAMED 18cda108-68b8-413d-a80b-40037e5c6324 61 fields · synced Jun 20, 2026