Identity
- Trade Name
- Rose retractor 13cm EUDAMED
- Device Name
- Rose retractor 13cm EUDAMED
- Model / Reference
- Bi10-350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103941480 EUDAMED
- Basic UDI-DI
- 896110394Bi10-350JF EUDAMED
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER 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: Hand-held surgical retractor, reusable
Rose retractor 13cm by Battan International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held surgical retractor, reusable.
- ATLAS — ATLAS CERRAHİ ALETLER LTD. ŞTİ. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Gimmi — Gimmi GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Sklar® — Sklar Corporation · Class I
- BIOCOMPOSITE PLUS ANCHOR Ø3, 5 MM W/NEEDLE — BMT BAPS BİYO MALZEME SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class III
- Spreizer / Spreader — REDA Instrumente GmbH · 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 | 896110394Bi10-350JF | 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 f6ef01c5-f551-4a7a-ab6e-7bf633ee97e9 61 fields · synced Jun 19, 2026