Identity
- Trade Name
- Balfour Retractor EUDAMED
- Device Name
- Balfour Retractor EUDAMED
- Model / Reference
- M08-001-00 EUDAMEDM08-005-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G410M08001000 EUDAMEDG410M08005000 EUDAMED
- Basic UDI-DI
- ++G410M0800100RP EUDAMED++G410M0800500SB EUDAMED
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Balfour Retractor by Mehrish Industries Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++G410M0800100RP | Class I | Active |
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Manufacturer
- Manufacturer
- Mehrish Industries Pvt Ltd
- EUDAMED SRN
- PK-MF-000031501
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (2)
- EUDAMED a10a8027-9d7d-4d2f-b65a-b1ef2f535c62 61 fields · synced Oct 6, 2026
- EUDAMED 7bdf7310-89b3-4f9a-a2ce-61cff9e02a71 61 fields · synced May 17, 2026