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Activa Instrument

EUDAMED

Class IIa (EU MDR)

Ref B-IP-3201Ref B-IP-2001Ref B-ISC-4000Ref B-II-1630BRef B-IPS-1000Ref B-ISC-1000Ref B-II-6000Ref B-ISS-1000Ref B-ISC-4500Ref B-IP-2703Ref B-IP-1502Ref B-ISC-1602Ref B-IP-1506Ref B-ISC-1601Ref B-ISC-1600Ref B-II-0815Ref B-IP-1503Ref B-ISC-1251Ref B-IP-2003Ref B-DIP-2700Ref B-IP-2004Model B-II-4000Ref B-DIP-1500Ref B-IS-2700Ref B-IS-4510Ref B-II-0830B

by Bioretec Ltd.

Identity

Trade Name
Activa Instrument EUDAMED
Device Name
K-Wire Ø3.2 mm, length 130 mm, for 3.2 mm pins/nails, 10 pcs. EUDAMED
K-Wire Ø2.0 mm, length 130 mm, for 2.0 mm pins/nails, 10 pcs. EUDAMED
Drill bit Ø3.2 mm, for 4.0 mm cannulated screws, quick coupling EUDAMED
K-wire Ø1.6 mm, length 300 mm, for 7/8/9/10/11 mm interference screw, blunt ends EUDAMED
Instrument set, for ActivaPin™ EUDAMED
ActivaScrew™ Cannulated Instrument Set EUDAMED
Drill bit Ø6.0 mm, cannulated, for 6 mm interference screws, quick coupling EUDAMED
ActivaScrew™ Instrument Set EUDAMED
Drill bit Ø3.5 mm, for 4.5 mm cannulated screws, quick coupling EUDAMED
Drill bit Ø2.7 mm, for 2.7 mm pins/nails, quick coupling EUDAMED
K-Wire Ø1.5 mm, length 130 mm, for 1.5 mm pins/nails, 10 pcs. EUDAMED
K-wire Ø1.6 mm, length 300 mm, trocar tip, measuring ring at 150 mm, for 4/4.5 mm cannulated screws EUDAMED
K-Wire Ø1.5 mm, length 260 mm, for 1.5 mm pins/nails EUDAMED
K-wire Ø1.6 mm, length 150 mm, trocar tip, for 4.0/4.5mm cannulated screws EUDAMED
K-wire Ø1.6 mm, length 150 mm, threaded tip, for 4.0/4.5mm cannulated screws EUDAMED
K-wire Ø0.8 mm, length 150 mm, for 4/ 5/6 mm interference screw EUDAMED
Drill bit Ø1.5 mm, for 1.5 mm pins/nails, quick coupling EUDAMED
K-wire Ø1.25 mm, length 150 mm, trocar tip, for 3.5mm cannulated screws EUDAMED
Drill bit Ø2.0 mm, for 2.0 mm pins/nails, quick coupling EUDAMED
Applicator with K-Wire Ø2.8 mm, disposable, for 2.7 mm pins EUDAMED
K-Wire Ø2.0 mm, length 260 mm, arthroscopic, for 2.0 mm pins/nails EUDAMED
Drill bit Ø4.0 mm, cannulated, for 4 mm interference screws, quick coupling EUDAMED
Applicator with K-Wire Ø1.6 mm, disposable, for 1.5 mm pins EUDAMED
Drill bit Ø2.0 mm, for 2.7 mm screws, quick coupling EUDAMED
Drill bit Ø3.2 mm, for 4.5 mm screws up to length 70 mm, quick coupling EUDAMED
K-wire Ø0.8 mm, length 300 mm, for 4/5/6 mm interference screw, blunt ends EUDAMED
Model / Reference
B-IP-3201 EUDAMED
B-IP-2001 EUDAMED
B-ISC-4000 EUDAMED
B-II-1630B EUDAMED
B-IPS-1000 EUDAMED
B-ISC-1000 EUDAMED
B-II-6000 EUDAMED
B-ISS-1000 EUDAMED
B-ISC-4500 EUDAMED
B-IP-2703 EUDAMED
B-IP-1502 EUDAMED
B-ISC-1602 EUDAMED
B-IP-1506 EUDAMED
B-ISC-1601 EUDAMED
B-ISC-1600 EUDAMED
B-II-0815 EUDAMED
B-IP-1503 EUDAMED
B-ISC-1251 EUDAMED
B-IP-2003 EUDAMED
B-DIP-2700 EUDAMED
B-IP-2004 EUDAMED
B-II-4000 EUDAMED
B-DIP-1500 EUDAMED
B-IS-2700 EUDAMED
B-IS-4510 EUDAMED
B-II-0830B EUDAMED

Identifiers

Primary DI / UDI-DI
06438394002708 EUDAMED
06438394002685 EUDAMED
06438394005167 EUDAMED
06438394010987 EUDAMED
06438394005310 EUDAMED
06438394005693 EUDAMED
06438394009059 EUDAMED
06438394003934 EUDAMED
06438394005297 EUDAMED
06438394000285 EUDAMED
06438394010956 EUDAMED
06438394007161 EUDAMED
06438394010963 EUDAMED
06438394005631 EUDAMED
06438394005143 EUDAMED
06438394009066 EUDAMED
06438394000261 EUDAMED
06438394005617 EUDAMED
06438394000278 EUDAMED
06438394002333 EUDAMED
06438394000407 EUDAMED
06438394009035 EUDAMED
06438394002319 EUDAMED
06438394001305 EUDAMED
06438394003231 EUDAMED
06438394010970 EUDAMED
Basic UDI-DI
B-06438394002708 EUDAMED
B-06438394002685 EUDAMED
B-06438394005167 EUDAMED
B-06438394010987 EUDAMED
B-06438394005310 EUDAMED
B-06438394005693 EUDAMED
B-06438394009059 EUDAMED
B-06438394003934 EUDAMED
B-06438394005297 EUDAMED
B-06438394000285 EUDAMED
B-06438394010956 EUDAMED
B-06438394007161 EUDAMED
B-06438394010963 EUDAMED
B-06438394005631 EUDAMED
B-06438394005143 EUDAMED
B-06438394009066 EUDAMED
B-06438394000261 EUDAMED
B-06438394005617 EUDAMED
B-06438394000278 EUDAMED
B-06438394002333 EUDAMED
B-06438394000407 EUDAMED
B-06438394009035 EUDAMED
B-06438394002319 EUDAMED
B-06438394001305 EUDAMED
B-06438394003231 EUDAMED
B-06438394010970 EUDAMED
EMDN Code
L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
L0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Finland EUDAMED

Clinical & Handling

Sterile

No

EUDAMEDEUDAMED

Implantable

No

EUDAMED

Reusable

Yes

EUDAMEDEUDAMED

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: Bone cutting forceps, reusable

Activa Instrument by Bioretec Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Bone cutting forceps, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Bioretec Ltd.
EUDAMED SRN
FI-MF-000001328

Sources (26)

  • EUDAMED 5d696a4a-907b-48fe-9fec-60137e07e59e 61 fields · synced Sep 18, 2026
  • EUDAMED efd6a21c-470c-4b66-b691-2fee2b107dc9 61 fields · synced May 11, 2026
  • EUDAMED d0f7aae4-2fbb-4dbe-8392-0c34a586dbbc 61 fields · synced May 16, 2026
  • EUDAMED a1ce92d4-315d-4611-a895-21d3d5294dbb 61 fields · synced May 16, 2026
  • EUDAMED fd07f1cc-f36a-4783-a9ff-d47f5e9b9632 61 fields · synced May 16, 2026
  • EUDAMED 47743e55-f02c-43ef-b587-0a2847a8f3fd 61 fields · synced May 16, 2026
  • EUDAMED 45bdb386-e036-4a19-a446-ef7343f6fe27 61 fields · synced May 16, 2026
  • EUDAMED b0c0c762-36a2-4a9b-a196-ef9a20421bcc 61 fields · synced May 17, 2026
  • EUDAMED 078a9d18-8103-46a9-8ad0-872c532b77d3 61 fields · synced May 17, 2026
  • EUDAMED 4a1a394b-25b7-444f-b2f0-cb358e94f65a 61 fields · synced May 17, 2026
  • EUDAMED e8065acb-f9c1-4e56-81a8-9da1999c9010 61 fields · synced May 17, 2026
  • EUDAMED aa8e78e0-8269-4080-8ca4-8a662afd5718 61 fields · synced May 17, 2026
  • EUDAMED f577c777-9f93-4314-b4b7-c40e2dfa6533 61 fields · synced May 17, 2026
  • EUDAMED e91eaca6-e292-4319-b1e5-3f3a5b534818 61 fields · synced May 17, 2026
  • EUDAMED 0077cbd5-1ac5-49de-b83d-6c50d1333e81 61 fields · synced May 18, 2026
  • EUDAMED 476cb1ad-9dcc-4080-b4b1-29921050dfc9 61 fields · synced May 18, 2026
  • EUDAMED 4122643c-3454-4ebe-b8da-50185a5e6e72 61 fields · synced May 18, 2026
  • EUDAMED d766bd4a-5530-40a0-b58a-335bff9d579a 61 fields · synced May 18, 2026
  • EUDAMED ad5574ab-7840-4d87-82dd-6a49382f4da4 61 fields · synced May 18, 2026
  • EUDAMED 77d93c5c-31ee-43ea-a195-7cf93b3a77ef 61 fields · synced May 18, 2026
  • EUDAMED eab53125-8129-45f5-b80d-3b82fc1dff55 61 fields · synced May 18, 2026
  • EUDAMED 67d84aa0-10d4-4fe9-b4fe-8a7d246a6e17 61 fields · synced May 18, 2026
  • EUDAMED b2513694-2a38-4c9d-ac9c-8e04321ac888 61 fields · synced May 19, 2026
  • EUDAMED ecadb28e-dcd1-40dd-9262-26694b662d4b 61 fields · synced May 19, 2026
  • EUDAMED 9d4226b1-2654-42e1-a721-d62968355e53 61 fields · synced May 19, 2026
  • EUDAMED ea52ac05-55b5-473c-be55-585c4006b01b 61 fields · synced May 19, 2026