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Acu-Punch
FDA 510(k)EUDAMED510(k) K831635Ref P625Ref P1050Ref P410Ref P1510Ref P810Ref P3525Ref P2510Ref P850Ref P2550Ref P310Ref P725Ref P210Ref P250Ref P4525Ref P1210Ref P610Ref P750Ref P110Ref P825Ref P150
Identity
- Trade Name
- ACU-PUNCH EUDAMEDACU-PUNHC EUDAMED
- Device Name
- ACU-PUNCH EUDAMED
- Model / Reference
- P625 EUDAMEDP1050 EUDAMEDP410 EUDAMEDP1510 EUDAMEDP810 EUDAMEDP3525 EUDAMEDP2510 EUDAMEDP850 EUDAMEDP2550 EUDAMEDP310 EUDAMEDP725 EUDAMEDP210 EUDAMEDP250 EUDAMEDP4525 EUDAMEDP1210 EUDAMEDP610 EUDAMEDP750 EUDAMEDP110 EUDAMEDP825 EUDAMEDP150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10814105020972 EUDAMED20814105021006 EUDAMED00814105021484 EUDAMED00814105021439 EUDAMED00814105021699 EUDAMED10814105020934 EUDAMED00814105021453 EUDAMED20814105020993 EUDAMED20814105020917 EUDAMED00814105021460 EUDAMED10814105020989 EUDAMED00814105021446 EUDAMED20814105020900 EUDAMED00814105021729 EUDAMED00814105021712 EUDAMED00814105021675 EUDAMED20814105020986 EUDAMED00814105020807 EUDAMED10814105020996 EUDAMED20814105020887 EUDAMED
- Basic UDI-DI
- B-10814105020972 EUDAMEDB-20814105021006 EUDAMEDB-00814105021484 EUDAMEDB-00814105021439 EUDAMEDB-00814105021699 EUDAMEDB-10814105020934 EUDAMEDB-00814105021453 EUDAMEDB-20814105020993 EUDAMEDB-20814105020917 EUDAMEDB-00814105021460 EUDAMEDB-10814105020989 EUDAMEDB-00814105021446 EUDAMEDB-20814105020900 EUDAMEDB-00814105021729 EUDAMEDB-00814105021712 EUDAMEDB-00814105021675 EUDAMEDB-20814105020986 EUDAMEDB-00814105020807 EUDAMEDB-10814105020996 EUDAMEDB-20814105020887 EUDAMED
- 510(k) Number
- K831635 FDA 510(k)
- EMDN Code
- A01020302 CUTANEOUS BIOPSY PUNCHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
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
Acu-Punch by Acuderm, Inc. — MDD, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | N/A | Active |
| FDA 510(k) | United States | FDA_510K | K831635 | N/A | Active |
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Manufacturer
- Manufacturer
- Acuderm, Inc.
Sources (21)
- FDA 510(k) K831635 24 fields · synced Aug 4, 2026
- EUDAMED f8df71d8-51c4-462a-a8d2-c95e7cbeb405 61 fields · synced Jun 20, 2026
- EUDAMED ce0a54fb-cf72-4529-b418-d414829dfffe 61 fields · synced Jul 9, 2026
- EUDAMED e94c328a-f64b-48f9-9e4c-b2e0d72a2607 61 fields · synced Jul 9, 2026
- EUDAMED 3d736239-81b3-4118-905f-55e429472412 61 fields · synced Jul 11, 2026
- EUDAMED 65f956d7-8a51-4025-b57a-ee3f12ce58ed 61 fields · synced Jul 11, 2026
- EUDAMED bd5ee859-c92b-412d-ab44-9476ca6d1f61 61 fields · synced Jul 11, 2026
- EUDAMED 38531e0f-5953-4ba1-88fe-2a0498a3c7bf 61 fields · synced Jul 14, 2026
- EUDAMED 93415c86-ca41-4a2d-8e54-a5332a27f2a9 61 fields · synced Jul 15, 2026
- EUDAMED a7b8c612-ab85-48b1-a61e-90c95290f29e 61 fields · synced Jul 16, 2026
- EUDAMED 4891f02c-11b9-40b3-b8fa-db989df97ef0 61 fields · synced Jul 16, 2026
- EUDAMED 0668dc21-ec5a-4cc3-859f-703d42fea77c 61 fields · synced Jul 17, 2026
- EUDAMED ca944ed1-af8e-4879-9dd8-758831b9d5b4 61 fields · synced Jul 18, 2026
- EUDAMED 8a49fef0-5f4a-4f4f-9fe5-e5329ea92d0b 61 fields · synced Jul 19, 2026
- EUDAMED 385f3ded-0bb3-448f-98bf-4d669aceba1a 61 fields · synced Jul 20, 2026
- EUDAMED 7fcbcf9b-b0dc-4199-945d-8577a07dd6a3 61 fields · synced Jul 21, 2026
- EUDAMED 3ecabad2-b537-4a65-8244-d8c04a7bd43c 61 fields · synced Jul 24, 2026
- EUDAMED 0d6fc8bf-644d-4200-b634-ad8c281ca20f 61 fields · synced Jul 25, 2026
- EUDAMED 09fee220-d1d9-43ce-8e50-24a0f2621c03 61 fields · synced Jul 27, 2026
- EUDAMED a0328dde-15c2-4510-8ebb-84491fe595a8 61 fields · synced Jul 29, 2026
- EUDAMED f2966820-4cb3-440c-a8fa-f8cb9e10ebb7 61 fields · synced Aug 4, 2026