Identity
- Trade Name
- Circulaveel - Gel rectal EUDAMED
- Device Name
- Rectal Gel EUDAMED
- Model / Reference
- PR01 EUDAMED19412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052990631025 EUDAMED
- Basic UDI-DI
- 805299063PROCTO001UW EUDAMED
- EMDN Code
- G99 GASTROINTESTINAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Circulaveel - Gel rectal 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 0596f442-c903-4e05-9fac-e26f4b2a2310 61 fields · synced Jun 18, 2026