BUG MEDIUM 869 NARROW BASE (black) LIGHT GREY GREEN
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- BUG MEDIUM 869 NARROW BASE (black) LIGHT GREY GREEN EUDAMEDBUG FDA UDI
- Generic Name
- Assistive pushchair FDA UDI
- Device Name
- BUG EUDAMEDPostural sitting unit intended for children with disabilities (Infantile Cerebral Palsy, degenerative pathologies with functional impairments, syndromic pathologies with impairments functional) easily adaptable thanks to its modularity. Suitable for users who have little or no control of the trunk and head and needing appropriate stabilization a pelvic level to be able to assume, in situations where residual functionality allows it, the more appropriate posture in different everyday contexts, both internally and externally. FDA UDI
- Model / Reference
- BUG EUDAMED47 EUDAMEDBUG MEDIUM 869 NARROW BASE (black) LIGHT GREY GREEN FDA UDI
- Description
- Postural sitting unit intended for children with disabilities (Infantile Cerebral Palsy, degenerative pathologies with functional impairments, syndromic pathologies with impairments functional) easily adaptable thanks to its modularity. Suitable for users who have little or no control of the trunk and head and needing appropriate stabilization a pelvic level to be able to assume, in situations where residual functionality allows it, the more appropriate posture in different everyday contexts, both internally and externally. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055715703069 EUDAMEDFDA UDI
- Basic UDI-DI
- 805571570BUGL9 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y180939 MODULAR POSTURE SYSTEMS EUDAMED
- GMDN Term
- Assistive pushchair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Assistive ergonomic chair, manually-adjusted
BUG MEDIUM 869 NARROW BASE (black) LIGHT GREY GREEN by ORMESA S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805571570BUGL9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ORMESA S.r.l.
- EUDAMED SRN
- IT-MF-000034824
Sources (2)
- EUDAMED 39c2810c-8557-4ed2-93a7-53661590f2f9 61 fields · synced Jul 11, 2026
- FDA UDI 5a5b90e1-8258-40d2-ba83-731526c4f08a 33 fields · synced May 30, 2026