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Nextech
EUDAMEDClass IIa (EU MDR)
Ref PCS21Model Carbon Steel Surgical Blades- 21 (size)Ref PCS24 (Secondary)Model Carbon Steel Surgical Blades- 24 (Size)Ref BPS4.0 (Secondary)Model Biopsy Punch- 4.0mm (Size)Ref BPS2.0 (Secondary)Model Biopsy Punch - 2.0mm (size)Ref PCS11 (Tertiary)Model Carbon Steel Surgical Blades- 11 (size)Ref PCS10 (Primary)Model Carbon Steel Surgical Blades -10 (Size)Ref BPS6.0 (Secondary)Model Biopsy Punch - 6.0mm (Size)Ref BPS4.0 (Primary)Model Biopsy Punch - 4.0mm (size)Ref PCS15 (Tertiary)Model Carbon Steel Surgical Blades- 15(Size)Ref PCS24 (Tertiary)Model Carbon Steel Surgical Blades- 24(Size)Ref BPS2.0Model Biopsy Punch- 2.0mm (size)Ref BPS3.0 (Secondary)Model Biopsy Punch- 3.0mm (size)Ref BPS6.0 (Primary)Model Biopsy Punch- 6.0mm (size)Ref PCS20 (Secondary)Model Carbon Steel Surgical Blades - 20 (Size)Ref PCS15 (Secondary)Model Carbon Steel Surgical Blades - 15 (Size)Ref PCS20 (Primary)Model Carbon Steel Surgical Blades - 20 (size)Ref PCS23 (Tertiary)Model Carbon Steel Surgical Blades- 23 (size)Ref PCS10Model Carbon Steel Surgical Blades- 10 (size)Ref PCS22 (Primary)Model Carbon Steel Surgical Blades-22 (size)Ref BPS3.0 (Primary)Ref BPS5.0 (Secondary)Model Biopsy Punch - 5.0mm (Size)
Identity
- Trade Name
- Nextech EUDAMED
- Device Name
- Carbon Steel Surgical Blades EUDAMEDBiopsy Punch EUDAMED
- Model / Reference
- Carbon Steel Surgical Blades- 21 (size) EUDAMEDPCS21 EUDAMEDCarbon Steel Surgical Blades- 24 (Size) EUDAMEDPCS24 (Secondary) EUDAMEDBiopsy Punch- 4.0mm (Size) EUDAMEDBPS4.0 (Secondary) EUDAMEDBiopsy Punch - 2.0mm (size) EUDAMEDBPS2.0 (Secondary) EUDAMEDCarbon Steel Surgical Blades- 11 (size) EUDAMEDPCS11 (Tertiary) EUDAMEDCarbon Steel Surgical Blades -10 (Size) EUDAMEDPCS10 (Primary) EUDAMEDBiopsy Punch - 6.0mm (Size) EUDAMEDBPS6.0 (Secondary) EUDAMEDBiopsy Punch - 4.0mm (size) EUDAMEDBPS4.0 (Primary) EUDAMEDCarbon Steel Surgical Blades- 15(Size) EUDAMEDPCS15 (Tertiary) EUDAMEDCarbon Steel Surgical Blades- 24(Size) EUDAMEDPCS24 (Tertiary) EUDAMEDBiopsy Punch- 2.0mm (size) EUDAMEDBPS2.0 EUDAMEDBiopsy Punch- 3.0mm (size) EUDAMEDBPS3.0 (Secondary) EUDAMEDBiopsy Punch- 6.0mm (size) EUDAMEDBPS6.0 (Primary) EUDAMEDCarbon Steel Surgical Blades - 20 (Size) EUDAMEDPCS20 (Secondary) EUDAMEDCarbon Steel Surgical Blades - 15 (Size) EUDAMEDPCS15 (Secondary) EUDAMEDCarbon Steel Surgical Blades - 20 (size) EUDAMEDPCS20 (Primary) EUDAMEDCarbon Steel Surgical Blades- 23 (size) EUDAMEDPCS23 (Tertiary) EUDAMEDCarbon Steel Surgical Blades- 10 (size) EUDAMEDPCS10 EUDAMEDCarbon Steel Surgical Blades-22 (size) EUDAMEDPCS22 (Primary) EUDAMEDBPS3.0 (Primary) EUDAMEDBiopsy Punch - 5.0mm (Size) EUDAMEDBPS5.0 (Secondary) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903175091533 EUDAMED18903175091561 EUDAMED18903175091592 EUDAMED18903175091578 EUDAMED28903175091506 EUDAMED08903175091496 EUDAMED18903175091615 EUDAMED08903175091595 EUDAMED28903175091513 EUDAMED28903175091568 EUDAMED08903175091571 EUDAMED18903175091585 EUDAMED08903175091618 EUDAMED18903175091523 EUDAMED18903175091516 EUDAMED08903175091526 EUDAMED28903175091551 EUDAMED28903175091490 EUDAMED08903175091540 EUDAMED08903175091588 EUDAMED18903175091608 EUDAMED
- Basic UDI-DI
- B-08903175091533 EUDAMEDB-18903175091561 EUDAMEDB-18903175091592 EUDAMEDB-18903175091578 EUDAMEDB-28903175091506 EUDAMEDB-08903175091496 EUDAMEDB-18903175091615 EUDAMEDB-08903175091595 EUDAMEDB-28903175091513 EUDAMEDB-28903175091568 EUDAMEDB-08903175091571 EUDAMEDB-18903175091585 EUDAMEDB-08903175091618 EUDAMEDB-18903175091523 EUDAMEDB-18903175091516 EUDAMEDB-08903175091526 EUDAMEDB-28903175091551 EUDAMEDB-28903175091490 EUDAMEDB-08903175091540 EUDAMEDB-08903175091588 EUDAMEDB-18903175091608 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMEDA01020302 CUTANEOUS BIOPSY PUNCHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
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
Category: Manual scalpel blade, single-use
Nextech by Paramount Surgimed Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08903175091533 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paramount Surgimed Limited
- EUDAMED SRN
- IN-MF-000021682
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (21)
- EUDAMED 8d50817a-851b-479f-8d9d-72f22be2dcdc 61 fields · synced Aug 3, 2026
- EUDAMED fa9eb70f-ed9a-4539-9fba-311fa1c68884 61 fields · synced May 16, 2026
- EUDAMED bc62d475-43f1-431f-85a8-9365e75f6d95 61 fields · synced May 16, 2026
- EUDAMED e32b150e-76af-4a90-a1a7-59357ad0cd8b 61 fields · synced May 17, 2026
- EUDAMED dfc89ae3-f59f-4d0b-9912-da2a6a1b0197 61 fields · synced May 17, 2026
- EUDAMED 5495c96b-a42c-4db1-90b8-fc058a556995 61 fields · synced May 17, 2026
- EUDAMED c64efbec-fb00-453f-a239-5428527dac65 61 fields · synced May 17, 2026
- EUDAMED dbbf0546-e093-4e07-b78b-903ae9c8df98 61 fields · synced May 17, 2026
- EUDAMED 3fa3a97f-8d73-49f1-99e1-93b45a5af03f 61 fields · synced May 18, 2026
- EUDAMED f2b1f0e3-b38d-48b5-843a-6bc4b3efae9b 61 fields · synced May 18, 2026
- EUDAMED f70c2ae0-54eb-42a2-b436-6576842d4e52 61 fields · synced May 18, 2026
- EUDAMED 5f1652d3-81d6-44d7-ab54-806da2d699e5 61 fields · synced May 18, 2026
- EUDAMED aeff868d-8e3e-48f9-aad9-eca3397d5b1d 61 fields · synced May 18, 2026
- EUDAMED ec24aeee-4488-4110-830f-308610306a05 61 fields · synced May 18, 2026
- EUDAMED 244d6be2-eb94-4839-b302-479dfe28023f 61 fields · synced May 18, 2026
- EUDAMED 6c11ec5c-1a3c-45f5-a405-1ea68ca7cd64 61 fields · synced May 18, 2026
- EUDAMED 6e4cf49f-b220-4b07-926b-5b2f81342799 61 fields · synced May 18, 2026
- EUDAMED d533394b-41fa-4c64-ae1a-8106dbce42a3 61 fields · synced May 18, 2026
- EUDAMED 25683568-985a-4963-810e-9d43b9042408 61 fields · synced May 19, 2026
- EUDAMED 60be80a8-97b9-4ef2-b168-c90b80932ce0 61 fields · synced May 19, 2026
- EUDAMED 50c41f68-395e-4d37-8d0d-820aeebfbf63 61 fields · synced May 19, 2026