Identity
- Trade Name
- Symmetry ® EUDAMED
- Device Name
- Hand Retractors EUDAMED
- Model / Reference
- 46-3015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840113241514 EUDAMED
- Basic UDI-DI
- 08401132HandRetractorHC 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
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
Symmetry ® by Aspen Surgical Products, Inc. — 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 | 08401132HandRetractorHC | Class I | Active |
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Manufacturer
- Manufacturer
- Aspen Surgical Products, Inc.
- EUDAMED SRN
- US-MF-000008255
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c11af2f7-0bc1-46f2-9f14-c5fbeaba8857 61 fields · synced Jul 13, 2026