Identity
- Trade Name
- Biolife Orthogel EUDAMED
- Device Name
- Mouth Ulcer EUDAMED
- Model / Reference
- 073187 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-073187P4 EUDAMED
- Basic UDI-DI
- B-073187P4 EUDAMED
- EMDN Code
- M04041503 DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Biolife Orthogel by PK Benelux BV — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-073187P4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED 30b0bc12-6433-4fd1-a8ab-5c1ec93f9295 61 fields · synced Jun 18, 2026