Identity
- Device Name
- Single Use Retractor EUDAMED
- Model / Reference
- SUBH-17772 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B969SUBH17772 EUDAMED
- Basic UDI-DI
- ++B969SURETRACTORLE EUDAMED
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Single Use Retractor by B&H Surgical Instrument — 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 | ++B969SURETRACTORLE | Class I | Active |
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Manufacturer
- Manufacturer
- B&H Surgical Instrument
- EUDAMED SRN
- PK-MF-000012820
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 5396a21c-2111-4b5d-9ae4-1aab53163946 61 fields · synced Jun 18, 2026