Identity
- Trade Name
- Allen EUDAMED
- Device Name
- UED-Linen or Cushion Set EUDAMED
- Model / Reference
- A-60102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00615521031015 EUDAMED
- Basic UDI-DI
- 0615521GMN1010057F EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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: Surgical retraction system, reusable
Allen by Hill-Rom, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retraction system, reusable.
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- Thompson — Thompson Surgical Instruments · Class I
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- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · 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 | 0615521GMN1010057F | Class I | Active |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
- EUDAMED SRN
- US-MF-000007306
- Authorised Representative
- Hill-Rom S.A.S. FR-AR-000003177
Sources (1)
- EUDAMED dadf1411-c48e-4432-bbe3-de662c8e9bdb 61 fields · synced May 22, 2026