Identity
- Trade Name
- PELNAC EUDAMED
- Device Name
- PELNAC EUDAMED
- Model / Reference
- PN-R82120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547531515550 EUDAMED
- Basic UDI-DI
- B-04547531515550 EUDAMED
- EMDN Code
- M04041002 ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pelnac by Gunze Limited — Class III — 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-04547531515550 | Class III | Active |
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Manufacturer
- Manufacturer
- Gunze Limited
- EUDAMED SRN
- JP-MF-000015551
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d1555c86-9ba3-4cfc-aa70-e6f083f06736 61 fields · synced May 23, 2026