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Post Op Tscope Premier
EUDAMEDClass I (EU MDR)
Ref 08814Model DOC 201-05 POST-OP TSCOPE & WEE ROM PED
by Breg, Inc.
Identity
- Trade Name
- POST OP TSCOPE PREMIER EUDAMED
- Model / Reference
- DOC 201-05 POST-OP TSCOPE & WEE ROM PED EUDAMED08814 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00672736023549 EUDAMED
- Basic UDI-DI
- 0672736000508L EUDAMED
- EMDN Code
- Y06121201 PASSIVE KNEE-ANKLE-FOOT ORTHOSES 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
Post Op Tscope Premier by Breg, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0672736000508L | Class I | Active |
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Manufacturer
- Manufacturer
- Breg, Inc.
- EUDAMED SRN
- US-MF-000018362
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 2858423f-ee71-4d5e-895e-1b4a93324aee 61 fields · synced Jul 30, 2026