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Sechrist Monoplace Hyperbaric Chamber and Gurney
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 4100HR
Identity
- Trade Name
- Sechrist Monoplace Hyperbaric Chamber and Gurney EUDAMEDSechrist Industries, Inc. FDA UDI
- Generic Name
- Hyperbaric chamber, stationary FDA UDI
- Device Name
- Sechrist Monoplace H-Series Hyperbaric Chamber EUDAMEDHBO CHMBR,ASSY,41IN,RVRS,ENGL,BLUE,CLASSIC FDA UDI
- Model / Reference
- 4100HR EUDAMED4100HR-00-0 FDA UDI
- Description
- HBO CHMBR,ASSY,41IN,RVRS,ENGL,BLUE,CLASSIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899660002413 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00899660002413 EUDAMED
- 510(k) Number
- K100268 FDA UDI
- FDA Product Code
- CBF FDA UDI
- EMDN Code
- Z120308 HYPERBARIC CHAMBERS EUDAMED
- GMDN Term
- Hyperbaric chamber, stationary FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5470 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 55 Inch FDA UDIHeight — 85 Inch FDA UDIWeight — 3500 Pound FDA UDIDepth — 116 Inch FDA UDI
Sechrist Monoplace Hyperbaric Chamber and Gurney by Sechrist Industries Inc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00899660002413 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Sechrist Industries Inc
- EUDAMED SRN
- US-MF-000017869
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 566a9868-b78c-45a2-860c-39cc55d2aaa2 61 fields · synced Jun 19, 2026
- FDA UDI 77be90d7-97ec-4f4a-9a7e-aca22db9fd54 36 fields · synced May 30, 2026