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Pelnac
EUDAMEDClass III (EU MDR)
Ref PN-D82120Ref PN-S82060Ref PN-D20030Ref PN-F200240Ref PN-S82090TRef PN-D82090Ref PN-S120240TRef PN-R40060Ref PN-S82120TRef PN-R20030Ref PN-D82060Ref PN-S40060Ref PN-S20030TRef PN-S200240TRef PN-S120240Ref PN-D40030Ref PN-F82090Ref PN-R82090Ref PN-R82060Ref PN-R200240Ref PN-F40060Ref PN-S40030T
Identity
- Trade Name
- PELNAC EUDAMED
- Device Name
- PELNAC EUDAMED
- Model / Reference
- PN-D82120 EUDAMEDPN-S82060 EUDAMEDPN-D20030 EUDAMEDPN-F200240 EUDAMEDPN-S82090T EUDAMEDPN-D82090 EUDAMEDPN-S120240T EUDAMEDPN-R40060 EUDAMEDPN-S82120T EUDAMEDPN-R20030 EUDAMEDPN-D82060 EUDAMEDPN-S40060 EUDAMEDPN-S20030T EUDAMEDPN-S200240T EUDAMEDPN-S120240 EUDAMEDPN-D40030 EUDAMEDPN-F82090 EUDAMEDPN-R82090 EUDAMEDPN-R82060 EUDAMEDPN-R200240 EUDAMEDPN-F40060 EUDAMEDPN-S40030T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04548762686415 EUDAMED04548762686385 EUDAMED04901420422617 EUDAMED04548762583431 EUDAMED04548366608561 EUDAMED04548762686408 EUDAMED04548366608509 EUDAMED04548366293149 EUDAMED04548366608578 EUDAMED04901420422587 EUDAMED04548762686392 EUDAMED04523783747529 EUDAMED04548366608523 EUDAMED04548366608516 EUDAMED04523783747550 EUDAMED04523783747574 EUDAMED04547531515536 EUDAMED04547531515567 EUDAMED04547531515574 EUDAMED04548762583417 EUDAMED04548366293125 EUDAMED04548366608530 EUDAMED
- Basic UDI-DI
- B-04548762686415 EUDAMEDB-04548762686385 EUDAMEDB-04901420422617 EUDAMEDB-04548762583431 EUDAMEDB-04548366608561 EUDAMEDB-04548762686408 EUDAMEDB-04548366608509 EUDAMEDB-04548366293149 EUDAMEDB-04548366608578 EUDAMEDB-04901420422587 EUDAMEDB-04548762686392 EUDAMEDB-04523783747529 EUDAMEDB-04548366608523 EUDAMEDB-04548366608516 EUDAMEDB-04523783747550 EUDAMEDB-04523783747574 EUDAMEDB-04547531515536 EUDAMEDB-04547531515567 EUDAMEDB-04547531515574 EUDAMEDB-04548762583417 EUDAMEDB-04548366293125 EUDAMEDB-04548366608530 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-04548762686415 | 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 (22)
- EUDAMED 7e5f3ce6-fe33-41dd-83de-00660d15cfda 61 fields · synced Aug 4, 2026
- EUDAMED 4d20dd99-08b6-46ab-921d-465c2e3e6481 61 fields · synced May 16, 2026
- EUDAMED 7d7808fc-d8c6-4311-8af6-51e31f9703b8 61 fields · synced May 17, 2026
- EUDAMED 58602720-01e6-4a0b-9762-b90276e7e866 61 fields · synced May 17, 2026
- EUDAMED d825b25b-67eb-4496-aeae-2ef577d05c71 61 fields · synced May 17, 2026
- EUDAMED 696bfaef-7740-4847-be27-56497abac538 61 fields · synced May 17, 2026
- EUDAMED 64b04454-fa4d-48e5-8268-9153d9d96a52 61 fields · synced May 17, 2026
- EUDAMED ee3592e9-f4b7-41f9-9c96-0a29b3964195 61 fields · synced May 17, 2026
- EUDAMED 91ca71c2-b25b-4141-87c0-c720fc23c87b 61 fields · synced May 17, 2026
- EUDAMED d722d5a6-c70d-416f-84cf-1405f9986bd4 61 fields · synced May 18, 2026
- EUDAMED 9737dcaa-7d44-4d83-837f-f9ba37ce2bab 61 fields · synced May 18, 2026
- EUDAMED c04caea1-1748-45b5-81c4-1ff7e8e55e9d 61 fields · synced May 18, 2026
- EUDAMED 9aa05745-4ce4-4a52-a6a5-6927c13e5166 61 fields · synced May 18, 2026
- EUDAMED a153b0e5-8d66-4a09-8ede-911a300c94f2 61 fields · synced May 18, 2026
- EUDAMED 3e7ec83b-257a-4cd2-b62a-c645235c5d9c 61 fields · synced May 18, 2026
- EUDAMED 692623bf-9ed5-499f-b7dd-fd8b71bb850a 61 fields · synced May 18, 2026
- EUDAMED 41e329a3-3dad-441c-85a7-fe81d6a394a6 61 fields · synced May 18, 2026
- EUDAMED c25a29e6-3693-4bfb-b96e-2eb2bc242ff3 61 fields · synced May 18, 2026
- EUDAMED 9ab3415d-5299-47c1-80eb-90348e5fa164 61 fields · synced May 18, 2026
- EUDAMED 612dc683-73e4-4686-8d1b-7c7bd23c89c0 61 fields · synced Jul 16, 2026
- EUDAMED 71a2cc38-cdb6-47e0-8b95-4869830437b0 61 fields · synced Jul 22, 2026
- EUDAMED e5d2051e-3426-47e8-b120-c9673460a674 61 fields · synced Jul 31, 2026