Identity
- Trade Name
- Simon bone curette EUDAMED
- Device Name
- Simon bone curette EUDAMED
- Model / Reference
- Bi8-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943378 EUDAMED
- Basic UDI-DI
- 896110394Bi8-300EB EUDAMED
- EMDN Code
- L0901 ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Bone curette, reusable
Simon bone curette by Battan International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone curette, reusable.
- Symmetry Bruns — SYMMETRY SURGICAL INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Spinal System — BIOMET SPINE LLC · Class I
- Life Instruments — Life Instrument Corporation · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Volkmann Bone Curette Oval - Fig. 00 17 cm - 6 3/4" Scoop Size 4.4 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 896110394Bi8-300EB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Battan International
- EUDAMED SRN
- PK-MF-000043557
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 433d06a8-2731-4b33-879b-65ff8a50e242 61 fields · synced Jun 19, 2026